Atlas FDA

KSEA BIPOLAR ELECTRODE

FDA 510(k) clearance K122983 · decided 2013-06-26

Clearance details

K-number
K122983
Device name
KSEA BIPOLAR ELECTRODE
Applicant
KARL STORZ Endoscopy-America, Inc.
Decision
Substantially Equivalent
Date received
2012-09-26
Decision date
2013-06-26
Days to decision
273 days
Clearance type
Traditional
Product code
HIN
Device class
2
Regulation number
884.4150
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
El Segundo, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Photodynamic Diagnostic D-Light C System (P050027/S034)KARL STORZ Endoscopy-America, Inc.2025-10-01
KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033)KARL STORZ Endoscopy-America, Inc.2025-05-02
KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032)KARL STORZ Endoscopy-America, Inc.2024-09-27
KARL STORZ D-Light C PDD System (P050027/S031)KARL STORZ Endoscopy-America, Inc.2023-05-05
KARL STORZ D-Light C PDD System (P050027/S030)KARL STORZ Endoscopy-America, Inc.2022-03-17
KARL STORZ D-Light C PDD System (P050027/S028)KARL STORZ Endoscopy-America, Inc.2022-02-04
KARL STORZ D-Light C PDD System (P050027/S029)KARL STORZ Endoscopy-America, Inc.2021-10-13
D-Light C PDD System (P050027/S027)KARL STORZ Endoscopy-America, Inc.2021-01-08