Atlas FDA

UTERINE CLAMPS

FDA 510(k) clearance K891402 · decided 1989-03-29

Clearance details

K-number
K891402
Device name
UTERINE CLAMPS
Applicant
Zinnanti Surgical Instruments, Inc.
Decision
Substantially Equivalent
Date received
1989-03-14
Decision date
1989-03-29
Days to decision
15 days
Clearance type
Traditional
Product code
HGC
Device class
1
Regulation number
884.4520
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Chatsworth, 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
GUSBERG HYSTERECTOMY CLAMP (K771344)J. Sklar Mfg. Co., Inc.1977-07-27

Recalls involving this device

No recalls on record reference this clearance.