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) → GDM — Needle, Aspiration And Injection, Reusable # GDM · Needle, Aspiration And Injection, Reusable _General, Plastic Surgery · 21 CFR 878.4800 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM ## Overview - **Product Code:** GDM - **Device Name:** Needle, Aspiration And Injection, Reusable - **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 (20 of 48) Showing 20 most recent of 48 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K071732](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K071732.md) | MARROWMINER | Stemcor Systems, Inc. | Sep 24, 2007 | SESE | | [K971114](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K971114.md) | BIOACCESS MARROW HARVEST SYSTEM | Bioaccess, Inc. | Jun 3, 1997 | SESE | | [K953082](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K953082.md) | ILIAC CREST BONE MARROW ASPIRATION NEEDLE | Baxter Healthcare Corp | Sep 22, 1995 | SESE | | [K953064](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K953064.md) | BIOACCESS MARROW HARVEST SYSTEM | Bioaccess, Inc. | Aug 7, 1995 | SESE | | [K936207](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K936207.md) | ENDO-NEEDLE INSTRUMENT | Gerard Medical, Inc. | Jun 16, 1994 | SESE | | [K930160](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K930160.md) | ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE | Symbiosis Corp. | Jul 6, 1993 | SESE | | [K923872](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K923872.md) | BONE MARROW BIOPSY SYSTEM | The Straumann Co. | Dec 15, 1992 | SESE | | [K915572](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K915572.md) | BECTON DICKINSON MODIFIED MENGHINI NEEDLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Feb 3, 1992 | SESE | | [K904667](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K904667.md) | NA NEEDLES | Olympus Corp. | Dec 12, 1990 | SESE | | [K903750](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K903750.md) | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E | Downs Surgical , Ltd. | Oct 31, 1990 | SESE | | [K903749](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K903749.md) | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U | Downs Surgical , Ltd. | Oct 31, 1990 | SESE | | [K903748](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K903748.md) | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V | Downs Surgical , Ltd. | Oct 31, 1990 | SESE | | [K903747](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K903747.md) | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U | Downs Surgical , Ltd. | Oct 31, 1990 | SESE | | [K902177](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K902177.md) | MANAN BONE BIOPSY NEEDLE | Manan Medical Products, Inc. | Sep 5, 1990 | SESE | | [K901995](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K901995.md) | PLEURA BIOPSY DEVICE | Mill-Rose Laboratory | Jul 10, 1990 | SESE | | [K895752](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K895752.md) | DIAMOND BLADE SURGICAL KNIVES | Magnum Diamond, Inc. | Oct 17, 1989 | SESE | | [K895594](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K895594.md) | SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE | Go Medical Industries Pty. , Ltd. | Oct 6, 1989 | SESE | | [K895551](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K895551.md) | ROCKET BONE MARROW NEEDLE | A & A Medical, Inc. | Oct 6, 1989 | SESE | | [K890722](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K890722.md) | ADG BONE BIOPSY SYSTEM | American Design Group, Inc. | Sep 21, 1989 | SESE | | [K891537](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM/K891537.md) | CORE BIOPSY NEEDLE, CATALOG CODE #54006 | Dlp, Inc. | Apr 18, 1989 | SESE | ## Top Applicants - Downs Surgical , Ltd. — 5 clearances - Popper & Sons, Inc. — 3 clearances - Radiation Development Co., Inc. — 2 clearances - Go Medical Industries Pty. , Ltd. — 2 clearances - E.L. Medico Intl., Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDM) **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