Atlas FDA

LEEP SYSTEM 1000

FDA 510(k) clearance K952483 · decided 1995-10-06

Clearance details

K-number
K952483
Device name
LEEP SYSTEM 1000
Applicant
CooperSurgical, Inc.
Decision
Substantially Equivalent
Date received
1995-05-30
Decision date
1995-10-06
Days to decision
129 days
Clearance type
Traditional
Product code
HGI
Device class
2
Regulation number
884.4120
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
North Attleboro, MA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch CooperSurgical

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
IRIS Thermocoagulator and Digital Colposcope (K202915)Liger Medical, LLC2021-04-23
Liger Medical HTU-110 (K152843)Liger Medical, LLC2016-06-24
FMWAND FERROMAGNETIC SURGICAL SYSTEM (K130606)Domain Surgical, Inc.2014-01-03
DOMAIN SURGICAL SYSTEM (K121881)Domain Surgical, Inc.2012-10-18
ENDOCERVICAL ELECTRODE # 2 (K070877)Modern Medical Equipment Mfg., Ltd.2007-07-27
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 (K061651)Apple Medical Corp.2006-10-20
THOMAS MEDICAL ELECTRODES (K022593)Thomas Medical, Inc.2002-11-01
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY (K003608)Aesculap, Inc.2001-02-20
TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 (K002042)New England Medical Corp.2001-02-01
LOOP ELECTRODE, BALL ELECTRODE (K993527)Palm Medical USA, Inc.2000-07-06
DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES (K993777)R-Group Intl.2000-05-25
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) (K983840)Wallach Surgical Devices, Inc.1999-05-20

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Mara Water Vapor Ablation System (P160047/S039)CooperSurgical, Inc.2025-01-07
MARA Water Vapor Ablation System (P160047/S035)CooperSurgical, Inc.2024-07-11
MARA Water Vapor Ablation System (P160047/S038)CooperSurgical, Inc.2024-07-09
MARA Water Vapor Ablation System (P160047/S036)CooperSurgical, Inc.2024-05-10
Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode (P160047/S034)CooperSurgical, Inc.2023-12-08
MARA Water Vapor Ablation System (P160047/S033)CooperSurgical, Inc.2023-10-25
Mara Water Vapor Ablation System (P160047/S031)CooperSurgical, Inc.2023-07-28
Mara Water Vapor Ablation System (P160047/S032)CooperSurgical, Inc.2023-07-27