510(k) Report

FDA product code · Obstetrics and gynecology

Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

KNFClass II21 CFR 884.4160510(k) required45 decisions since 19774 recalls

45 FDA decisions since 1977. 510(k) reviews decided 2021–2025 took a median of 30 days (half between 23 and 99). 4 recalls name this code, 0 of them Class I. The most-cited predicate is K070315, named by 5 later devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, obstetrics and gynecology panel

Twenty years of KNF 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 · KNF

1in 2025

2007: 12010: 12012: 12013: 12014: 12018: 12020: 12021: 12022: 12023: 12024: 12025: 12026 (partial year): 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNF

Too few KNF 510(k)s in any year since 2007 to give a median.

Recalls per year · KNF

1in 2013

2009: 32013: 1
2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KNF

93in 2025

2008: 22009: 12010: 142011: 152012: 42013: 242014: 82015: 72016: 92017: 222018: 132019: 182020: 192021: 92022: 162023: 332024: 132025: 93
2007high 93 (2025) · low 0 (2007)2025

MAUDE reports naming product code KNF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—02
20090—31
20101—014
20110—015
20121—04
20131—124
20141—08
20150—07
20160—09
20170—022
20181—013
20190—018
20201—019
20211—09
20221—016
20231—033
20241—013
20251—093
20261—0—
FIG. 1 — KNF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KNF? 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) Report

Related product codes

Other codes under 21 CFR 884.4160.