Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4800](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4800) → GAB — Needle, Suturing, Disposable

# GAB · Needle, Suturing, Disposable

_General, Plastic Surgery · 21 CFR 878.4800 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAB

## Overview

- **Product Code:** GAB
- **Device Name:** Needle, Suturing, Disposable
- **Regulation:** [21 CFR 878.4800](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4800)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K012199](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAB/K012199.md) | DIGICAP | Humana USA, Inc. | Dec 19, 2001 | SESE |
| [K980988](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAB/K980988.md) | AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) | Axya Medical, Inc. | May 11, 1998 | SESE |
| [K932591](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAB/K932591.md) | ENDO-JUDGE | Synergistic Medical Technologies, Inc. | Dec 22, 1993 | SESE |
| [K895681](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAB/K895681.md) | CONTRAST BACKGROUND MATERIAL | Applied Medical Technologies | Oct 24, 1989 | SESE |
| [K863595](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAB/K863595.md) | COATED SUTURE NEEDLE | Sharpoint, Inc. | Oct 24, 1986 | SESE |
| [K831648](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAB/K831648.md) | ANCHOR BRAND SURGICAL NEEDLES | Anchor Products Co. | Aug 16, 1983 | SESE |
| [K812444](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAB/K812444.md) | RADIATION STERILIZATION FOR NEEDLE CNTR | Devon Industries, Inc. | Dec 14, 1981 | SESE |
| [K801976](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAB/K801976.md) | SCANLAN STERNUM NEEDLE-SUTURE | Scanlan Intl., Inc. | Sep 26, 1980 | SESE |

## Top Applicants

- Anchor Products Co. — 1 clearance
- Applied Medical Technologies — 1 clearance
- Axya Medical, Inc. — 1 clearance
- Devon Industries, Inc. — 1 clearance
- Humana USA, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAB](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAB)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com