Atlas FDA

FORCE 2

FDA 510(k) clearance K921884 · decided 1992-12-15

Clearance details

K-number
K921884
Device name
FORCE 2
Applicant
Valleylab, Inc.
Decision
Substantially Equivalent
Date received
1992-04-21
Decision date
1992-12-15
Days to decision
238 days
Clearance type
Traditional
Product code
HGI
Device class
2
Regulation number
884.4120
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Boulder, CO, 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
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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.