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) → FHQ — Holder, Needle, Gastroenterologic

# FHQ · Holder, Needle, Gastroenterologic

_Gastroenterology, Urology · 21 CFR 876.4730 · Class 1_

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

## Overview

- **Product Code:** FHQ
- **Device Name:** Holder, Needle, Gastroenterologic
- **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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K974327](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHQ/K974327.md) | WINGED NEEDLE HOLDER | Phx Technologies Corp. | Jan 9, 1998 | SESE |
| [K924196](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHQ/K924196.md) | LAPAROSCOPIC NEEDLE HOLDER | Nusurg, Inc. | Jun 25, 1993 | SESE |
| [K930330](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHQ/K930330.md) | ENDOSCOPIC NEEDLEHOLDER, MODIFICATION | Holmed Corp. | Jun 8, 1993 | SESE |
| [K920706](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHQ/K920706.md) | MAGNETIC POINT GUARD FOR SURGICAL NEEDLES | Retrax | May 26, 1993 | SESE |
| [K851780](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHQ/K851780.md) | 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS | Artiberia | Jun 20, 1985 | SESE |
| [K851779](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHQ/K851779.md) | 25-100,25-220 VARIOUS NEEDLE HOLDERS | Artiberia | Jun 20, 1985 | SESE |
| [K771859](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHQ/K771859.md) | NEEDLE HOLDER, MICROVASCULAR | Edward Weck, Inc. | Oct 4, 1977 | SESE |

## Top Applicants

- Artiberia — 2 clearances
- Retrax — 1 clearance
- Phx Technologies Corp. — 1 clearance
- Nusurg, Inc. — 1 clearance
- Holmed Corp. — 1 clearance

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

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