FDA product code NWU: Endoscope Introducer Kit
NWU is the FDA product code for endoscope introducer kit. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under NWU, from 3 different applicants. The average 510(k) review took 99 days (median 59). FDA has posted 25 recalls for NWU devices, 25 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Endoscope Introducer Kit |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NWU clearance
Top NWU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Candela Laser Corp. | 1 | 1994-02-10 |
| American Pharmaseal Div. Ahsc | 1 | 1987-12-03 |
| Inmed Corp. | 1 | 1981-12-14 |
Most recent NWU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933268 | Candela Laser Corp. | CANDELA GUIDEWIRE | 1994-02-10 | 219 |
| K874045 | American Pharmaseal Div. Ahsc | PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER | 1987-12-03 | 59 |
| K813332 | Inmed Corp. | BRISTOL BALLON INTRODUCER, MANDRIL SET | 1981-12-14 | 20 |
Recalls for NWU devices
25 product recalls in 23 recall events; 25 initiated in the last five years and 25 still open. Most recent: 2026-08-18.
| Year | Recalls |
|---|---|
| 2022 | 2 |
| 2023 | 5 |
| 2024 | 9 |
| 2025 | 6 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code NWU?
NWU is the FDA product code for endoscope introducer kit. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is NWU?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NWU?
Across 3 cleared submissions the average was 99 days from receipt to decision (median 59).
Which companies have the most NWU clearances?
Candela Laser Corp. (1); American Pharmaseal Div. Ahsc (1); Inmed Corp. (1).
Have NWU devices been recalled?
Yes: 25 product recalls across 23 recall events; the most recent began 2026-08-18.
Next steps
- Run an FDA pathway report with predicate devices for product code NWU
- Run a recall and safety report across every NWU manufacturer
- Watch product code NWU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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