Atlas FDA

UNIVERSAL SURGICAL INSTRUMENT HOLDER

FDA 510(k) clearance K924713 · decided 1993-05-17

Clearance details

K-number
K924713
Device name
UNIVERSAL SURGICAL INSTRUMENT HOLDER
Applicant
T. Korossurgical Instruments Corp.
Decision
Substantially Equivalent
Date received
1992-09-18
Decision date
1993-05-17
Days to decision
241 days
Clearance type
Traditional
Product code
FWW
Device class
1
Regulation number
878.4960
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Moorepark, 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
OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM (K953961)Osteonics Corp.1995-11-29
CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES (K935356)Amsco American Sterilizer Co.1994-03-23
FISK ARM SUPPORT (K931876)Vvortex International Corp.1993-09-09
TABLE, OPERATING ROOM, HYDRAULIC (K863161)Kamiya Tsusan Kaisha, Ltd.1986-09-05
SKYTRON ELITE 300 SURGERY TABLE (K853479)Skytron, Div. the Kmw Group, Inc.1985-09-05

Recalls involving this device

No recalls on record reference this clearance.