NWUClass II

Endoscope Introducer Kit

21 CFR 876.1500 / Gastroenterology, Urology

NWU is the FDA product code for Endoscope Introducer Kit, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k))...". As of 2026-09-10, FDA records hold 3 510(k) clearances under this code, the most recent dated 1994-02-10, and 24 recalls.

Classification record

Product code: NWU
Device name: Endoscope Introducer Kit
FDA definition: This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Regulation: 21 CFR 876.1500
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: FDA code 7
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 3
Ingested recalls: 25

Clearances, product code NWU

By decision year

3 clearances under product code NWU with a decision year between 1981 and 1994, 1981 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code NWU by decision year
Year	Clearances
1981	1
1987	1
1994	1

Applicants with the most clearances

Product code NWU

Applicants holding the most 510(k) clearances under product code NWU
Applicant	Clearances
American Pharmaseal Div. Ahsc	1
Candela Corporation	1
Inmed Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order