Atlas FDA

DERMAHOOK #382-805

FDA 510(k) clearance K771187 · decided 1977-07-11

Clearance details

K-number
K771187
Device name
DERMAHOOK #382-805
Applicant
Edward Weck, Inc.
Decision
Substantially Equivalent
Date received
1977-07-01
Decision date
1977-07-11
Days to decision
10 days
Clearance type
Traditional
Product code
GDG
Device class
1
Regulation number
878.4800
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
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
MODIFIED PGL ABSORBABLE STAPLE* (K900069)United States Surgical, A Division of Tyco Healthc1990-04-16
SKIN HOOKS, VARIOUS TYPES (K891898)Zinnanti Surgical Instruments, Inc.1989-04-12
RAYLOR(TM) DISSECTING HOOK (K864425)Cedar Surgical, Inc.1986-12-12
BRIMFIELD CANNULATED GRASPING HOOKS (K843136)Brimfield Scientific Instruments1984-09-25
SURGICAL HOOKS, VARIOUS (K841010)Premier Dental Products Co.1984-05-01
SURGICAL RETRACTOR & ELASTIC STAYS, DISP (K812562)Humboldt Products1981-10-02
MIDDLE EAR PICKS, HOOKS CURETTES, (K791120)Xomed, Inc.1979-07-10
NERVE APPROXIMATER (K780289)Edward Weck, Inc.1978-06-14
ABRAMSON TRACHEA HOOK & RETRACTOR (K771190)Edward Weck, Inc.1977-07-11

Recalls involving this device

RecordFirmDate
Weck, DuraHook", Catalog #382800, 1/4" (6mm) Neuro Elastic Retractors, Sterile, Rx only. recall (Z-1856-2008)Telefelx Medical2008-09-04
Weck, DermaHook", Catalog #382805, 1/2" (12mm) Neuro Elastic Retractors, Sterile, Rx only, recall (Z-1857-2008)Telefelx Medical2008-09-04