Atlas FDA

HIN

16 FDA 510(k) clearances · Product code

100 daysmedian time to decision
317 days90th percentile
16clearances measured

FDA profile

Official device name
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4150
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2013: 14 · 2014: 12 · 2015: 8 · 2024: 29 · 2025: 43 · 2026: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PK Lap Loop (K142525)Olympus Winter & Ibe GmbH2014-11-21
LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE (K130305)Lina Medical Aps2013-07-24
KSEA BIPOLAR ELECTRODE (K122983)KARL STORZ Endoscopy-America, Inc.2013-06-26
PKS BILL (K122605)Gyrus Acmi, Inc.2012-12-05
TUBALGATOR (K113080)Mectra Labs, Inc.2012-06-29
VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS (K111751)ETHICON, Inc.2011-12-02
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) (K111059)Gyrus Acmi, Inc.2011-09-01
BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 (K990147)Richard Wolf Medical Instruments Corp.1999-04-16
BICOAG COAGULATING FORCEPS (K971565)Everest Medical Corp.1998-03-12
ELMED LBC 50-P (K926517)Elmed, Inc.1994-11-15
COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES (K943776)Richard Wolf Medical Instruments Corp.1994-11-03
STI TISSUE MANIPULATOR (K911699)Surgical Technologies, Inc.1991-06-13
MODEL 26021C BIPOLAR COAGULATOR (K871745)KARL STORZ Endoscopy-America, Inc.1987-07-10
TRACOR, CANNULA, BICEPTS BIPOLAR (K790043)Neomed Corp.1979-02-08
FORCEPS, ELECTROSURGICAL (K781109)Kli1978-09-14
ONE INCISION BI-POLAR ELECTRO. FORCEPS (K781089)Kli1978-07-17

Track HIN automatically

Every clearance here is in the API, with alerts when new ones post.