Balfour Retractor: Parts, Specifications and FDA Classification

General product information only, not medical advice and not a procedure guide.

Short answer

A Balfour retractor is a reusable, self-retaining abdominal retractor: a frame that holds a wound open with side blades, often with a center blade. In US regulation it falls under the general-use manual surgical instrument rule, 21 CFR 878.4800, which is Class I and exempt from premarket notification. The Class II rule that sometimes gets quoted, 882.4800, covers neurosurgical retractors only.

Definition and scope

NLM AccessGUDID describes the device type behind Balfour listings as a hand-operated, self-retaining, one-piece surgical instrument used to separate or draw aside the margins of a wound or incision to allow access to tissues and organs during open surgery. The two Balfour records in AccessGUDID (Symmetry and Sontec) both carry the GMDN term "Self-retaining surgical retractor, reusable" (checked 2026-10-30).

For the wider family of retractor types, see what a surgical retractor is; this page stays on the Balfour pattern.

Balfour retractor parts and specifications as listed

Product records describe a Balfour as a set of named components with specifications. One AccessGUDID record (Symmetry Balfour, Aspen Surgical Products) is described as "Retractor, Balfour Abdominal, w/Center Blade, 3 1/2 in Deep (Side), 16 in Spread". A second record (Sontec Instruments) is titled "Balfour Retractor with double bar". The listing language gives this checklist of what a catalogue entry specifies:

Listing element	What the record states
Pattern	Balfour, abdominal (Symmetry record)
Center blade	Named as part of the configuration ("w/Center Blade")
Side blade depth	Stated in inches (3 1/2 in in the Symmetry record)
Spread	Stated in inches (16 in in the Symmetry record)
Frame variant	"Double bar" in the Sontec record

Dimensions and configurations differ by manufacturer and model, so two products both called Balfour may not be interchangeable. Blade design is covered separately in retractor blades.

How FDA classifies a Balfour retractor

21 CFR 878.4800, "Manual surgical instrument for general use", defines the device as a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended for various general surgical procedures. The list of included devices names "retractor". Under paragraph (b) it is Class I (general controls) and exempt from the premarket notification procedures in subpart E of part 807, subject to the limitations in 878.9 (eCFR, checked 2026-10-30).

Both AccessGUDID records mark the device as exempt from premarket submission. They list different FDA product codes (GAD "Retractor" on one, FFO "Retractor, Self-Retaining" on the other), so a code mismatch between two vendors’ listings is not by itself a sign of an error.

Reusable status and reprocessing in the listings

• Both records answer single-use as No, and GMDN calls the device reusable.
• The Symmetry record states the device is not packaged sterile and requires sterilization prior to use, listing moist heat or steam sterilization.
• The Sontec record also states sterilization prior to use is required, listing steam and dry heat.
• Both records state the labeling contains no MRI safety information.

Cleaning and sterilization parameters belong to each manufacturer’s instructions for use, which a facility should follow for its own model. For a related self-retaining design, see the Gelpi retractor, and for a wound-protector style device see the Alexis retractor.

Where it matters for labs, clinics and supply decisions

Listing fields form a short specification checklist for anyone reading or comparing catalogue entries: the pattern name, whether a center blade is included, side blade depth, spread, frame variant, reusable versus single-use, whether it ships sterile, and the sterilization methods the labeling lists. Because the Class I rule is shared by general-use hand instruments, the classification itself does not distinguish between manufacturers; the model-level fields above do.

Common misunderstandings

• "It is Class II." 21 CFR 882.4800, "Self-retaining retractor for neurosurgery", is Class II, but that rule covers a self-locking device used to hold the edges of a wound open during neurosurgery. An abdominal Balfour is a general-use instrument under 878.4800.
• "Any listing with Balfour in the name is the same product." The two AccessGUDID records differ in manufacturer, product code and description.
• "Reusable means ready to use." The Symmetry record states it is not supplied sterile.

FAQ

What are the parts of a Balfour retractor?

Listings name side blades with a stated depth, a center blade in many configurations, and a spread dimension; one record names a double-bar frame. Exact parts vary by model.

Is a Balfour retractor reusable?

Yes in both AccessGUDID records: single-use is No and sterilization is required before use.

Does a Balfour retractor need FDA 510(k) clearance?

The records mark it exempt from premarket submission, consistent with Class I under 21 CFR 878.4800.

Sources

• eCFR, 21 CFR 878.4800 and 21 CFR 882.4800, checked 2026-10-30.
• NLM AccessGUDID, Symmetry Balfour (DI 00887482062098), checked 2026-10-30.
• NLM AccessGUDID, Balfour Retractor with double bar (DI 00192896071957), checked 2026-10-30.