MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,

Instrument, Biopsy

ETHICON ENDO-SURGERY, INC.

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Mammotome Hh Hand-held Probe, Vacuum Set, Control Module, Hh Hand-held Holster And Cables, Software Package, Footswitch,.

Pre-market Notification Details

• Device ID: K991980
• 510k Number: K991980
• Device Name: MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,
• Classification: Instrument, Biopsy
• Applicant: ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839
• Contact: Tamima Itani
• Correspondent: Tamima Itani; ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839
• Product Code: KNW
• CFR Regulation Number: 876.1075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-06-14
• Decision Date: 1999-08-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10841911101229	K991980	000
10841911100970	K991980	000
10841911100963	K991980	000
00841911100614	K991980	000
00841911100553	K991980	000
00841911101765	K991980	000
00841911101819	K991980	000