← Product Code [FFN](/submissions/GU/subpart-e%E2%80%94surgical-devices/FFN) · K892542

# RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU (K892542)

_Zinnanti Surgical Instruments, Inc. · FFN · May 9, 1989 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFN/K892542

## Device Facts

- **Applicant:** Zinnanti Surgical Instruments, Inc.
- **Product Code:** [FFN](/submissions/GU/subpart-e%E2%80%94surgical-devices/FFN.md)
- **Decision Date:** May 9, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.4730
- **Device Class:** Class 1
- **Review Panel:** Gastroenterology, Urology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFN/K892542](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFN/K892542)

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