← Product Code [KNN](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN) · K863385

# (ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE (K863385)

_Cook Urological, Inc. · KNN · Nov 4, 1986 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K863385

## Device Facts

- **Applicant:** Cook Urological, Inc.
- **Product Code:** [KNN](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN.md)
- **Decision Date:** Nov 4, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3920
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

A wheelchair component is a device intended for medical purposes that is generally sold as an integral part of a wheelchair, but may also be sold separately as a replacement part. Examples of wheelchair components are the following: Armrest, narrowing attachment, belt, extension brake, curb climber, cushion, antitip device, footrest, handrim, hill holder, leg rest, heel loops, and toe loops.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K863385](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K863385)

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