ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS

Laparoscope, General & Plastic Surgery

ABMEDICA SAS

The following data is part of a premarket notification filed by Abmedica Sas with the FDA for Abmedica Reusable Laparoscopic Hand Instruments And Trocars.

Pre-market Notification Details

• Device ID: K140101
• 510k Number: K140101
• Device Name: ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: ABMEDICA SAS 333 QUARRY ROAD Milford, CT 06460
• Contact: Daniel Donovan
• Correspondent: Daniel Donovan; ABMEDICA SAS 333 QUARRY ROAD Milford, CT 06460
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-01-15
• Decision Date: 2014-07-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
E496C35IBFS330	K140101	000
E496C05PN350	K140101	000
E496C05PN500	K140101	000
E496C05RS350	K140101	000
E496C05RS500	K140101	000
E496C05TU350	K140101	000
E496C05TU500	K140101	000
E496C05TUSC350	K140101	000
E496C05TUSC500	K140101	000
E496COEC35060RO0	K140101	000
E496COEC35075RO0	K140101	000
E496COEC35100RO0	K140101	000
E496COEC35120RO0	K140101	000
E496COEP35060H0	K140101	000
E496C05PC500	K140101	000
E496C05PC350	K140101	000
30653405006101	K140101	000
E496C05CT350	K140101	000
E496C05CT500	K140101	000
E496C05IPTG350	K140101	000
E496C05IPTG500	K140101	000
E496C05JH350	K140101	000
E496C05JH500	K140101	000
E496C05KG350	K140101	000
E496C05KG500	K140101	000
E496C05LH350	K140101	000
E496C05LH500	K140101	000
E496C05NS350	K140101	000
E496C05NS500	K140101	000
E496COEP35075H0	K140101	000
E496COEP35100H0	K140101	000
E496LILHBP10	K140101	000
E496LILHBP20	K140101	000
E496LILHBY10	K140101	000
E496LILHBY20	K140101	000
E496LILHGA10	K140101	000
E496LILHGA20	K140101	000
E496LILHGP10	K140101	000
E496LILHGP20	K140101	000
E496LILHGY10	K140101	000
E496LILHGY20	K140101	000
E496LILHRA10	K140101	000
E496LILHRA20	K140101	000
E496LILHRP10	K140101	000
E496LILHBP0	K140101	000
E496LILHBDA10	K140101	000
E496COEP35120H0	K140101	000
E496LILBTU200	K140101	000
E496LILBTU350	K140101	000
E496LILC0600	K140101	000
E496LILC0750	K140101	000
E496LILC1000	K140101	000
E496LILC100D0	K140101	000
E496LILC100RO0	K140101	000
E496LILC1200	K140101	000
E496LILCT200	K140101	000
E496LILCT330	K140101	000
E496LILHBA10	K140101	000
E496LILHBA20	K140101	000
E496LILHRP20	K140101	000
E496C35HBP0	K140101	000
10653405005797	K140101	000
10653405005865	K140101	000
10653405005872	K140101	000
10653405005889	K140101	000
10653405006145	K140101	000
E496LILIP2SC20ST0	K140101	000
E496C35IP2AL330	K140101	000
E496C35IP2BI330	K140101	000
E496C35IP2CL330	K140101	000
E496C35IP2DC330	K140101	000
E496C35IPS20330	K140101	000
E496C35IPSM330	K140101	000
20653405006159	K140101	000
10653405005940	K140101	000
10653405005841	K140101	000
10653405005834	K140101	000
10653405005803	K140101	000
10653405005896	K140101	000
10653405005919	K140101	000
10653405005926	K140101	000
10653405005971	K140101	000
10653405005902	K140101	000
E496C35HH330	K140101	000
E496COEC3501200	K140101	000
E496COEC350600	K140101	000
E496COEC350750	K140101	000
E496COEC351000	K140101	000
10653405005810	K140101	000
10653405005827	K140101	000
30653405005982	K140101	000
30653405005999	K140101	000
10653405006008	K140101	000
10653405006015	K140101	000
10653405006022	K140101	000
10653405006039	K140101	000
10653405006046	K140101	000
10653405006053	K140101	000
10653405006060	K140101	000
10653405006077	K140101	000
10653405006084	K140101	000
10653405006091	K140101	000
10653405006114	K140101	000
10653405006121	K140101	000
10653405006190	K140101	000
10653405005995	K140101	000
10653405005988	K140101	000
30653405006002	K140101	000
30653405006019	K140101	000
30653405006026	K140101	000
30653405006033	K140101	000
30653405006040	K140101	000
30653405006057	K140101	000
30653405006064	K140101	000
30653405006071	K140101	000
30653405006088	K140101	000
30653405006095	K140101	000
30653405006118	K140101	000
30653405006125	K140101	000
30653405006194	K140101	000
E496C35BTU330	K140101	000
E496LILHRY10	K140101	000
E496C35IP2F2330	K140101	000
E496C35RS330	K140101	000
E496C35SEAL10	K140101	000
E496C35SEAL30	K140101	000
E496C35ST2SCST1	K140101	000
E496C35TU330	K140101	000
E496C35TUSC330	K140101	000
E496C35CH330	K140101	000
E496C35CT330	K140101	000
E496C35IP2DM330	K140101	000
E496C35IPAL330	K140101	000
E496C35IPBK330	K140101	000
E496C35IPCL330	K140101	000
E496C35IPF20330	K140101	000
E496C35PN330	K140101	000
E496C35PC330	K140101	000
E496C35IP2F3330	K140101	000
E496C35IP2FS330	K140101	000
E496C35IP2SM330	K140101	000
E496C35IPCO330	K140101	000
E496C35IPF15330	K140101	000
E496C35IPF30330	K140101	000
E496C35IPF3B330	K140101	000
E496C35IPIC330	K140101	000
E496C35IPS15330	K140101	000
E496C35IPTF2330	K140101	000
E496C35IPTG330	K140101	000
E496C35KG330	K140101	000
E496C35NS330	K140101	000
E496LILIPF10200	K140101	000
E496LILIPF10310	K140101	000
E496C05IPCU500	K140101	000
E496C05IPF20350	K140101	000
E496C05IPF20500	K140101	000
E496C05IPF30350	K140101	000
E496C05IPF30500	K140101	000
E496C05IPF3B350	K140101	000
E496C05IPF3B500	K140101	000
E496C05IPS20350	K140101	000
E496C05IPS20500	K140101	000
E496LILIP2SM200	K140101	000
E496LILIP2SM310	K140101	000
E496LILIPSM200	K140101	000
E496LILIPSM310	K140101	000
E496C05IPCU350	K140101	000
E496C05IPBK500	K140101	000
E496C05IP2CL350	K140101	000
E496C05IP2CL500	K140101	000
E496C05IP2DC350	K140101	000
E496C05IP2DC500	K140101	000
E496C05IP2DM350	K140101	000
E496C05IP2DM500	K140101	000
E496C05IP2DS350	K140101	000
E496C05IP2DS500	K140101	000
E496C05IP2F2350	K140101	000
E496C05IP2F2500	K140101	000
E496C05IPAL350	K140101	000
E496C05IPAL500	K140101	000
E496C05IPBK350	K140101	000
E496LILIP2F3200	K140101	000
E496C35IP2F1330	K140101	000
E496LILHRY20	K140101	000
E496LILIP2SC200	K140101	000
E496LILIP2SC310	K140101	000
E496LILIPAL200	K140101	000
E496LILIPAL310	K140101	000
E496LILIPCL200	K140101	000
E496LILIPCL310	K140101	000
E496LILIPF20200	K140101	000
E496LILIPF20310	K140101	000
E496LILIPFS200	K140101	000
E496LILIPFS310	K140101	000
E496LILIPSS200	K140101	000
E496LILIPSS310	K140101	000
E496LILIPST200	K140101	000
E496LILIP2F3310	K140101	000
E496LILIP2F2310	K140101	000
E496LILHYA10	K140101	000
E496LILHYA20	K140101	000
E496LILHYP10	K140101	000
E496LILHYP20	K140101	000
E496LILHYY10	K140101	000
E496LILHYY20	K140101	000
E496LILIBFS200	K140101	000
E496LILIBFS350	K140101	000
E496LILIP2DM200	K140101	000
E496LILIP2DM310	K140101	000
E496LILIP2DS200	K140101	000
E496LILIP2DS310	K140101	000
E496LILIP2F2200	K140101	000
E496LILIPST310	K140101	000
E496LILJH200	K140101	000
E496LILPN330	K140101	000
E496LILRS200	K140101	000
E496LILRS330	K140101	000
E496LILT060C0	K140101	000
E496LILT060H0	K140101	000
E496LILT075H0	K140101	000
E496LILT100H0	K140101	000
E496LILT120H0	K140101	000
E496LILTU200	K140101	000
E496LILTU310	K140101	000
E296LILIP2SC31ST1	K140101	000
E296LILSEAL11	K140101	000
E296LILSEAL31	K140101	000
E496LILPN200	K140101	000
E496LILPC330	K140101	000
E496LILJH330	K140101	000
E496LILKG200	K140101	000
E496LILKG330	K140101	000
E496LILLH200	K140101	000
E496LILLH330	K140101	000
E496LILNS200	K140101	000
E496LILNS310	K140101	000
E496LILO060C0	K140101	000
E496LILO060H0	K140101	000
E496LILO075H0	K140101	000
E496LILO100H0	K140101	000
E496LILO120H0	K140101	000
E496LILPC200	K140101	000
E496C35IP2DS330	K140101	000