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) → FGM — Probe And Director, Gastro-Urology

# FGM · Probe And Director, Gastro-Urology

_Gastroenterology, Urology · 21 CFR 876.4730 · Class 1_

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

## Overview

- **Product Code:** FGM
- **Device Name:** Probe And Director, Gastro-Urology
- **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 |
| --- | --- | --- | --- | --- |
| [K041732](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGM/K041732.md) | CAVERMAP SURGICAL AID | Blue Torch Medical Technologies | Sep 21, 2004 | SESE |
| [K031527](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGM/K031527.md) | MODIFICATION TO CAVERMAP SURGICAL AID | Blue Torch Medical Technologies | Jun 5, 2003 | SESE |
| [K010098](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGM/K010098.md) | MODIFICATION TO CAVERMAP SURGICAL AID | Uromed Corp. | Feb 1, 2001 | SESE |
| [K993436](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGM/K993436.md) | CAVERMAP SURGICAL AID | Uromed Corp. | Feb 11, 2000 | SESE |
| [K944384](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGM/K944384.md) | ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG | Regulatory & Marketing Services, Inc. | Feb 15, 1995 | SESE |
| [K944379](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGM/K944379.md) | ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG | Regulatory & Marketing Services, Inc. | Feb 15, 1995 | SESE |
| [K944378](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGM/K944378.md) | ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG | Regulatory & Marketing Services, Inc. | Feb 15, 1995 | SESE |

## Top Applicants

- Regulatory & Marketing Services, Inc. — 3 clearances
- Uromed Corp. — 2 clearances
- Blue Torch Medical Technologies — 2 clearances

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

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