Written and maintained by CASRAI Editorial Board
Last updated
General product information only, not medical advice and not instructions for use in any procedure.
Short answer
A Richardson retractor is a hand-held surgical retractor: a manual instrument whose blade is held by hand, not locked open, to draw tissue aside. In the US, FDA files hand-held general retractors under product code GAD, 21 CFR 878.4800, Class I, exempt from premarket notification (checked 2026-10-30). Listings give length and blade dimensions, as the Richardson-Eastman example below shows.
Definition and scope
“Richardson retractor” is an instrument-pattern name used by suppliers and manufacturers. The name does not appear in the regulation. The regulation that governs the device describes it by function instead. 21 CFR 878.4800(a) defines a manual surgical instrument for general use as “a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures.” Instruments built for one specialty are covered by other regulations elsewhere in 21 CFR parts 868 to 892 (Cornell LII text of 21 CFR 878.4800, checked 2026-10-30).
Teleflex lists its Richardson-Eastman retractor under “General Retractors” and “Hand-Held Retractors” (reference MC-008133, item 480196, “Weck Pattern, bright finish”; manufacturer product page checked 2026-10-30). That is the pattern this guide uses as its worked example.
How a Richardson listing is read in practice
A supplier listing for this pattern is mostly a set of dimensions. Reading them in a fixed order avoids mixing up fields that look alike. The Teleflex Richardson-Eastman listing (item 480196) shows each field:
| Listing field | What the Teleflex listing states |
|---|---|
| Pattern and finish | Weck pattern, bright finish |
| Overall length | 9 7/8 in (25.0 cm) |
| Blade width | Blade A 1 1/8 in (29.0 mm); Blade B 7/8 in (22.0 mm) |
| Blade depth | Small 1 1/8 in (30.0 mm); large 1 in (24.0 mm) |
Two points follow from the listing itself. First, blade width and blade depth are separate columns, and blade width is given for two blades (A and B), so a single “size” figure is incomplete. Second, the page refers the reader to the Instructions for Use for indications, contraindications, warnings and precautions. Material, sterility and regulatory status are matters for the manufacturer’s IFU and labelling, not the dimension table.
Related instruments and how they differ
The Richardson name sits among many retractor patterns on the same regulation. CASRAI covers the neighbouring patterns in separate guides:
- What a surgical retractor is, for the general category.
- Deaver retractor and Army-Navy retractor, two other retractor patterns covered separately.
- Hohmann retractor, another retractor pattern covered separately.
- Balfour retractor, for a self-retaining design as a contrast to a hand-held one.
- Retractor blades, for blade terminology used in listings.
FDA also keeps a separate product code for self-retaining retractors: FFO, “Retractor, Self-Retaining”, Class I, 21 CFR 876.4730 (openFDA, checked 2026-10-30). A hand-held pattern such as the Richardson is listed by suppliers with the hand-held group instead.
Where it matters for labs, clinics and supply decisions
The classification record is short and checkable. openFDA lists product code GAD as device name “Retractor”, device class 1, regulation number 878.4800, panel General and Plastic Surgery, not an implant and not life-sustaining (openFDA classification data last updated 2026-10-19, checked 2026-10-30). 21 CFR 878.4800(b) classifies the device as Class I (general controls) and exempts it from premarket notification, subject to the limitations in 878.9.
For staff comparing listings, the practical consequence is that Class I status says how FDA regulates the instrument, and it says nothing about size, material or whether a given unit is sterile. Those come from the manufacturer’s listing and IFU. A product code is assigned per device by its manufacturer, so a specific product’s own labelling is the authority for its code.
Common misunderstandings
- “Richardson” is not a regulatory category. FDA classifies the device under the general retractor code, not by pattern name.
- Richardson and Richardson-Eastman are not interchangeable labels. Teleflex uses the name “Richardson-Eastman” for its listed product; compare dimensions rather than assuming two listings match.
- Class I does not mean unregulated. General controls still apply; the exemption is from premarket notification only.
- One length is not the whole size. Overall length, blade width and blade depth are reported separately.
FAQ
What is a Richardson retractor?
A hand-held surgical retractor pattern, listed by manufacturers such as Teleflex among general hand-held retractors.
What FDA class is a Richardson retractor?
Hand-held general retractors fall under product code GAD, 21 CFR 878.4800, Class I and exempt from premarket notification, subject to 878.9 (checked 2026-10-30). A specific product’s own labelling gives its code.
What dimensions does a Richardson-Eastman listing show?
The Teleflex item 480196 lists 9 7/8 in (25.0 cm) overall length, blade widths of 29.0 mm and 22.0 mm, and blade depths of 30.0 mm and 24.0 mm.
Is a Richardson retractor self-retaining?
The Teleflex listing places it under hand-held retractors. FDA’s separate self-retaining retractor code is FFO.
Sources
- Cornell LII, 21 CFR 878.4800, Manual surgical instrument for general use, checked 2026-10-30.
- openFDA device classification, product codes GAD and FFO, api.fda.gov, data updated 2026-10-19, checked 2026-10-30.
- Teleflex, Richardson-Eastman Retractor product page, checked 2026-10-30.
