Atlas FDA

ADJUSTABLE WRENCHES

FDA 510(k) clearance K874359 · decided 1987-11-23

Clearance details

K-number
K874359
Device name
ADJUSTABLE WRENCHES
Applicant
Med-Tool, Inc.
Decision
Substantially Equivalent
Date received
1987-10-23
Decision date
1987-11-23
Days to decision
31 days
Clearance type
Traditional
Product code
HXC
Device class
1
Regulation number
888.4540
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
St. Louis, MO, 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
Intellitorq (K180092)Gauthier Biomedical, Inc.2018-03-08
COMBINATION WRENCHES (K874358)Med-Tool, Inc.1987-11-23
TORQUEDRIVER WRENCH (K870053)Jerome Medical1987-03-11
SPINAL WRENCH (K813067)Twin City Surgical, Inc.1981-11-24
WRENCH (K791073)Truth, Inc.1979-06-20

Recalls involving this device

No recalls on record reference this clearance.