FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

OPTICAL FORCEPS

K Number: K990561 · Decision May 14, 1999
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
2
Applicant Total
5
Review Days
81

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Basic Information

Device Name
OPTICAL FORCEPS
K Number
K990561
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
874.4680
Medical Specialty
Ear, Nose, Throat
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Pilling Weck Surgical
Date Received
February 22, 1999
Decision Date
May 14, 1999
Product Code
JEK
Advisory Committee
Ear, Nose, Throat
Review Advisory Committee
EN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
JEK Forceps, Biopsy, Bronchoscope (Rigid)

Similar 510(k) Clearances

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Other Clearances by Pilling Weck Surgical

K Number Device Name
K992476 PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
K992174 PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
K990935 JACKSON ESOPHAGEAL DILATOR
K982128 SHIKANI-FRENCH SPEAKING VALVE