Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4730](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4730) → KOA — Surgical Instruments, G-U, Manual (And Accessories) # KOA · Surgical Instruments, G-U, Manual (And Accessories) _Gastroenterology, Urology · 21 CFR 876.4730 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA ## Overview - **Product Code:** KOA - **Device Name:** Surgical Instruments, G-U, Manual (And Accessories) - **Regulation:** [21 CFR 876.4730](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4730) - **Device Class:** 1 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) ## Identification A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 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 § 876.9. ## Recent Cleared Devices (20 of 44) Showing 20 most recent of 44 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K182664](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K182664.md) | FiXcision | Agency For Medical Innovations GmbH | Dec 7, 2018 | SESE | | [K950267](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K950267.md) | URETHRAL SUTURE GUIDE | Applied Medical Resources | Jan 31, 1995 | SESE | | [K932465](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K932465.md) | LI VASECTOMY | Femcare , Ltd. | Mar 2, 1994 | SESE | | [K921546](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K921546.md) | VASOVASOSTOMY SET | Cook Urological, Inc. | Jul 2, 1993 | SESK | | [K931181](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K931181.md) | VESITEC SUTURE PASSER | Vesitec Medical, Inc. | May 12, 1993 | SESE | | [K921304](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K921304.md) | DDV LIGATOR | North American Medical, Inc. | Oct 5, 1992 | SESE | | [K922971](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K922971.md) | NO-SCALPEL VASCETOMY INSTRUMENTS | Pilling Co. | Sep 23, 1992 | SESE | | [K921228](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K921228.md) | BENDEREV PROTECT-A-PASS NEEDLE | Eimark Labs, Inc. | Sep 14, 1992 | SESE | | [K922192](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K922192.md) | VAS DILATOR | Cook Urological, Inc. | Aug 7, 1992 | SESE | | [K896058](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K896058.md) | GRASPING FORCEPS | Annex Medical, Inc. | Dec 28, 1989 | SESE | | [K891352](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K891352.md) | MARLOW ANAL SPECULUM | Simpson/Basye, Inc. | Jun 23, 1989 | SESE | | [K890218](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K890218.md) | MICROSURGICAL CYSTOTOME | Kinetic Medical Products | Jan 27, 1989 | SESE | | [K864963](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K864963.md) | STOMACH EVACULATOR - EWALD STYLE | Medovations, Inc. | Oct 14, 1987 | SESE | | [K863273](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K863273.md) | MARTIN MEDICAL PRO-SCOPE ANOSCOPE | Martin Medical | Nov 4, 1986 | SESE | | [K852014](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K852014.md) | EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA | Effner and Spreine Co. | Aug 7, 1985 | SESE | | [K852726](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K852726.md) | ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420 | The Huxley Instrument Corp. | Jul 9, 1985 | SESE | | [K852725](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K852725.md) | BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420 | The Huxley Instrument Corp. | Jul 9, 1985 | SESE | | [K851162](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K851162.md) | AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER | Van-Tec, Inc. | Apr 15, 1985 | SESE | | [K851113](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K851113.md) | RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR | The Huxley Instrument Corp. | Apr 3, 1985 | SESE | | [K851112](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA/K851112.md) | RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER | The Huxley Instrument Corp. | Apr 3, 1985 | SESE | ## Top Applicants - The Huxley Instrument Corp. — 5 clearances - Imm Enterprises , Ltd. — 4 clearances - Lone Star Medical Products, Inc. — 3 clearances - V. Mueller O.V. Baxter Healthcare Corp. — 3 clearances - Cook Urological, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KOA) **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. 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