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General product and regulatory information only, not medical advice. Use of any surgical device is decided by qualified clinicians following the manufacturer’s instructions for use.
Short answer
Endoloop is Ethicon’s trade name for a ligature: a length of suture supplied pre-formed into a loop with a knot, packed in a plastic tube. In FDA’s public device data, the Endoloop records are single-use, sterile, prescription-only absorbable suture devices (Class 2) listed under suture product codes. They are not the flexible endoscopic snare that FDA lists under product code FDI.
Definition and scope
Johnson and Johnson MedTech, which markets the product, states that the Endoloop ligature “facilitates the ligation of pedicles in laparoscopic procedures.” Its product page describes an 18-inch suture in a plastic tube, narrow at one end and scored at the other, with the suture formed into a loop with a knot. The page points to the Endoloop Ligature Instructions for Use (Ethicon, Inc.) for indications, contraindications, warnings, precautions and adverse reactions (checked 2026-10-30).
“Endoloop” is a brand name, so searches for it mix three things: the brand itself, the general idea of a pre-tied ligating loop, and the unrelated endoscopic snare. This page keeps them apart using FDA’s own records rather than distributor descriptions.
How the manufacturer describes it
- It is a ligature, meaning a suture used to tie off tissue, supplied as a ready-formed loop rather than a plain strand.
- The manufacturer’s stated use is ligation of pedicles in laparoscopic procedures.
- The catalogue numbers shown on the product page include EJ10G and EZ10G.
- Warnings, contraindications and technique are in the package insert, which are not reproduced here.
How FDA’s public data classifies it
The openFDA Unique Device Identification (UDI) database lists ENDOLOOP records from Ethicon Inc. The table compares the two records returned for the brand name (openFDA index last updated 2026-10-01; checked 2026-10-30). openFDA states its data is unvalidated and must not be used for medical decisions.
| Attribute | Model EJ10G | Model EZ10G |
|---|---|---|
| Labeled description | VICRYL VLT 0 45CM ENDOLOOP | PDS II VLT 0 107CM AG ST3 |
| FDA product code | GAM, Suture, Absorbable, Synthetic, Polyglycolic Acid | NEW, Suture, Surgical, Absorbable, Polydioxanone |
| Regulation number | 878.4493 | 878.4840 |
| Device class | 2 | 2 |
| GMDN term | Polyester suture, bioabsorbable, multifilament, non-antimicrobial | Polyester suture, bioabsorbable, monofilament, non-antimicrobial |
| Single-use | Yes | Yes |
| Sterile | Yes | Yes |
| Prescription use | Yes | Yes |
| Labeled as containing natural rubber latex | No | No |
| Distribution status | In commercial distribution | In commercial distribution |
Two things follow from the table. First, “Endoloop” is a family of products, not one fixed specification: the two records differ in suture description, length and product code. Second, FDA files them as absorbable sutures, which places them in the general and plastic surgery device panel, not in the gastroenterology panel.
Endoloop versus an endoscopic snare
The confusion is common because “loop” and “snare” are used loosely. FDA product code FDI is “Snare, Flexible” under 21 CFR 876.4300, Class 2, in the gastroenterology and urology panel (openFDA classification database, checked 2026-10-30). That regulation covers the endoscopic electrosurgical unit and its accessories, and names flexible snares and self-opening rigid snares among them (Cornell LII copy of 21 CFR 876.4300, checked 2026-10-30).
| Question | Endoloop (UDI records) | Flexible snare (FDI) |
|---|---|---|
| FDA product code(s) | GAM, NEW | FDI |
| Regulation | 878.4493, 878.4840 | 876.4300 |
| Regulatory grouping | Absorbable surgical suture | Endoscopic electrosurgical unit and accessories |
| Class | 2 | 2 |
Older ligating loops from other companies appear in the FDA 510(k) database under different product codes, for example K902731 (Endoscopic Hemostatic Ligating Loop, 1990) and K022410 (Saph-Loop Ligating Loop, 2002). Those listings show that “ligating loop” has been used as a device name by several manufacturers. They are not evidence about the Endoloop’s own clearance.
Where it matters for labs, clinics and supply records
Supply and records staff who handle catalogue data can use the same fields FDA publishes to avoid mislabelling an item:
- Record the model number, not only the brand. The two UDI records above carry different product codes and regulation numbers.
- Use the product code that matches the label. An Endoloop is not coded as a snare, and a snare is not coded as a suture.
- Check the single-use and sterile fields. Both Endoloop records are flagged single-use and sterile.
- Check the latex field. Neither record is labeled as containing natural rubber latex; the package labeling remains the authority.
- Read the instructions for use. Indications, warnings and adverse reactions come from the manufacturer’s package insert, not from catalogue data.
For related reading on device and supply vocabulary, see what an electrosurgical unit is, what a surgical retractor is, what a sterile drape is, the Medical Device Amendments of 1976 (the law behind FDA’s device classes) and Medical Device Reporting.
Common misunderstandings
- “Endoloop is a snare.” FDA’s snare code (FDI) and the Endoloop’s suture codes are different classifications.
- “Endoloop is one product.” UDI lists at least two models with different suture descriptions and lengths.
- “Endoloop is reusable.” Both UDI records are flagged single-use.
- “A product code tells you how to use it.” Product codes and regulation numbers classify the device; use is defined by the instructions for use.
FAQ
Is an Endoloop a snare?
No, not in FDA’s classification. The Endoloop records sit under absorbable suture product codes (GAM and NEW), while a flexible snare is product code FDI under 21 CFR 876.4300.
Is an Endoloop single-use?
Yes, according to the openFDA UDI records for models EJ10G and EZ10G, both flagged single-use and sterile (checked 2026-10-30).
What FDA class is an Endoloop?
Class 2 in both UDI records, under regulations 878.4493 (EJ10G) and 878.4840 (EZ10G).
What is an Endoloop made of?
That depends on the model. The UDI records describe EJ10G as a bioabsorbable multifilament polyester suture and EZ10G as a bioabsorbable monofilament polyester suture. The manufacturer’s instructions for use are the authority for any specific product.
Sources
- Johnson and Johnson MedTech, ENDOLOOP Ligature product page: jnjmedtech.com/en-US/product/endoloop-ligature (checked 2026-10-30).
- FDA openFDA device UDI API, brand name ENDOLOOP: api.fda.gov/device/udi.json (checked 2026-10-30).
- FDA openFDA device classification API, product codes FDI and GAM: api.fda.gov/device/classification.json (checked 2026-10-30).
- 21 CFR 876.4300, Endoscopic electrosurgical unit and accessories: law.cornell.edu/cfr/text/21/876.4300 (checked 2026-10-30).
- FDA openFDA 510(k) API, ligating loop clearances: api.fda.gov/device/510k.json (checked 2026-10-30).
