TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES

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 Trocars, Cannulae And Sheaths For Endoscopic And Laparoscopic Procedures.

Pre-market Notification Details

• Device ID: K940347
• 510k Number: K940347
• Device Name: TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: KARL STORZ ENDOSCOPY-AMERICA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109
• Contact: Johnathan S Kahan
• Correspondent: Johnathan S Kahan; KARL STORZ ENDOSCOPY-AMERICA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-01-25
• Decision Date: 1994-06-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04048551457290	K940347	000
04048551159217	K940347	000
04048551159231	K940347	000
04048551159248	K940347	000
04048551159262	K940347	000
04048551235409	K940347	000
04048551253083	K940347	000
04048551253106	K940347	000
04048551258965	K940347	000
04048551327197	K940347	000
04048551099223	K940347	000
04048551159156	K940347	000
04048551159125	K940347	000
04048551159088	K940347	000
04048551457313	K940347	000
04048551158715	K940347	000
04048551158739	K940347	000
04048551158746	K940347	000
04048551158784	K940347	000
04048551158807	K940347	000
04048551158906	K940347	000
04048551158944	K940347	000
04048551158968	K940347	000
04048551159064	K940347	000
04048551099247	K940347	000
04048551117378	K940347	000
04048551051160	K940347	000
04048551051191	K940347	000
04048551051221	K940347	000
04048551265970	K940347	000
04048551265994	K940347	000
04048551121030	K940347	000
04048551121047	K940347	000
04048551176351	K940347	000
04048551176368	K940347	000
04048551176375	K940347	000
04048551051153	K940347	000
04048551051108	K940347	000
04048551116814	K940347	000
04048551118993	K940347	000
04048551119068	K940347	000
04048551119334	K940347	000
04048551119440	K940347	000
04048551120613	K940347	000
04048551120897	K940347	000
04048551268025	K940347	000
04048551288603	K940347	000
04048551051962	K940347	000
04048551116807	K940347	000
04048551176382	K940347	000