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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Wallach Surgical Devices, Inc. — Predicate Candidate Screening

27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

98 daysmedian FDA review time
272 days90th percentile
27clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K021224ENDOCERVICAL BLOCK NEEDLEWallach Surgical Devices, Inc.2002-07-12860
K020711WALLACH LOOP ELECTRODEWallach Surgical Devices, Inc.2002-06-03900
K000768WALLACH QUANTUM 500 ELECTROSURGICAL GENERATORWallach Surgical Devices, Inc.2000-04-11330
K992736WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUMWallach Surgical Devices, Inc.1999-09-29470
K991669PMS 750 FINGERSWITCHWallach Surgical Devices, Inc.1999-08-12900
K983840WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)Wallach Surgical Devices, Inc.1999-05-202020
K984306`THE INSEMINATOR' (PROPOSED)Wallach Surgical Devices, Inc.1999-03-01890
K983208WALLACH QUANTUM 500 ELECTROSURGICAL GENERATORWallach Surgical Devices, Inc.1999-02-221610
K963653WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEMWallach Surgical Devices, Inc.1997-06-112720
K963348WALLACH INTEGRATION UNITWallach Surgical Devices, Inc.1997-03-192050
K950630WALLACH DIGITAL IMAGING SYSTEMWallach Surgical Devices, Inc.1995-11-222820
K921791WALLACH LEAP 100 ELECTRO SURGERY SYSTEMWallach Surgical Devices, Inc.1995-05-0411150
K943201CLEAN AIRWallach Surgical Devices, Inc.1995-02-282380
K935634WALLACH LEEP PROCEDURE KITWallach Surgical Devices, Inc.1994-07-202390
K935010WALLACH ULTRA FREEZEWallach Surgical Devices, Inc.1994-02-091120
K910491WALLACH COLD SOAKERWallach Surgical Devices, Inc.1991-05-211050
K902693WALLACH FLEXIBLE ENDOMETRIAL SAMPLERWallach Surgical Devices, Inc.1991-01-312260
K896065WALLACH CC/BRUSHWallach Surgical Devices, Inc.1990-01-04780
K880416WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEMWallach Surgical Devices, Inc.1988-09-262380
K871681PHOTOSTAR V-8Wallach Surgical Devices, Inc.1987-08-05980
K871683COLPOSTAR V-6Wallach Surgical Devices, Inc.1987-08-05980
K871682WALLACH CONVERTIBLE COLPOSCOPEWallach Surgical Devices, Inc.1987-06-24560
K854334PAINBLOCKER WA5000Wallach Surgical Devices, Inc.1986-04-301840
K853389WALLACH ZOOM COLPOSCOPEWallach Surgical Devices, Inc.1985-11-19980
K813402WA-2000 TEMPERATURE INDICATORWallach Surgical Devices, Inc.1982-01-12390
K813024WA1000Wallach Surgical Devices, Inc.1981-12-03360
K803311LL100 CRYOSURGICAL SYSTEMWallach Surgical Devices, Inc.1981-02-04333

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda