Atlas FDA

SILASTIC BRAND OBSTETRICAL VACUUM CUP

FDA 510(k) clearance K771558 · decided 1977-09-20

Clearance details

K-number
K771558
Device name
SILASTIC BRAND OBSTETRICAL VACUUM CUP
Applicant
Dow Corning Corp. Healthcare Industries Materials
Decision
Substantially Equivalent
Date received
1977-08-15
Decision date
1977-09-20
Days to decision
36 days
Clearance type
Traditional
Product code
HDB
Device class
2
Regulation number
884.4340
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Mchenry, IL, 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
Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) (K250298)Clinical Innovations, LLC2025-10-08
MEDELA SINGLE USE SILC CUP, MODEL 077.0791 (K041579)Medela AG2005-04-21
VACULINK, MODEL VCL 3000 (K043614)Medevco, Inc.2005-04-14
FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 (K021193)Fortune Medical Instrument Corp.2003-02-12
MITYVAC MERLIN, MODEL 10027 (K020447)Prism Enterprises, Inc.2002-04-12
SWIFT LOW PROFILE CUP (PRO CUP) (K013460)Swift Delivery Products2002-01-17
MITYVAC (K011532)Prism Enterprises, Inc.2001-07-30
KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M (K981260)Clinical Innovations, Inc.1998-09-22
AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP (K980976)Hollister, Inc.1998-08-21
MITYVAC (K980212)Prism Technologies, Inc.1998-07-09
SWIFT DELIVERY PRODUCT #300 (K973942)Swift Delivery Products1997-12-12
SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE (K970170)Richard G. Lindsay1997-03-28

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
THE SOFT RINSE SYSTEM (P800060/S007)Dow Corning Corp. Healthcare Industries Materials1991-03-05
SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S010)Dow Corning Corp. Healthcare Industries Materials1985-11-18
SILSOFT (ELASTOFILCON A ) CONTACT LENS (P800020/S007)Dow Corning Corp. Healthcare Industries Materials1985-11-05
THE SOFT RINSE SYSTEM (P800060/S006)Dow Corning Corp. Healthcare Industries Materials1985-07-30
SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S008)Dow Corning Corp. Healthcare Industries Materials1984-10-31
THE SOFT RINSE SYSTEM (P800060/S005)Dow Corning Corp. Healthcare Industries Materials1984-04-04
SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S009)Dow Corning Corp. Healthcare Industries Materials1984-03-12
SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S004)Dow Corning Corp. Healthcare Industries Materials1983-11-09