NON-INSULATED SCISSORS

Laparoscope, General & Plastic Surgery

KARL STORZ ENDOSCOPY-AMERICA, INC.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Non-insulated Scissors.

Pre-market Notification Details

Device IDK935073
510k NumberK935073
Device Name:NON-INSULATED SCISSORS
ClassificationLaparoscope, General & Plastic Surgery
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 ROBERTS BLVD. Kennesaw,  GA  30144
ContactPaul L Sumner
CorrespondentPaul L Sumner
KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 ROBERTS BLVD. Kennesaw,  GA  30144
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-25
Decision Date1994-01-31

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