FDA product code · Gastroenterology and urology
Laparoscope, General & Plastic Surgery, Reprocessed
23 FDA decisions since 2001. 12 recalls name this code, 0 of them Class I. The most-cited predicate is K062497, named by 2 later devices.
The "Endoscope and accessories, reprocessed" is intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NLM at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · NLM
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · NLM
284in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NLM
6so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NLM
10in 2025
MAUDE reports naming product code NLM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 284 | 0 | 2 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 1 | 11 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 1 | — | 0 | 82 |
| 2013 | 1 | — | 0 | 102 |
| 2014 | 1 | — | 0 | 84 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 2 | — | 1 | 39 |
| 2017 | 2 | — | 0 | 15 |
| 2018 | 0 | — | 1 | 9 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 6 | — |
Planning a device in NLM? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 876.1500.