Atlas FDA

HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE

FDA 510(k) clearance K013066 · decided 2001-12-11

Clearance details

K-number
K013066
Device name
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
Applicant
Olympus America, Inc.
Decision
Substantially Equivalent
Date received
2001-09-12
Decision date
2001-12-11
Days to decision
90 days
Clearance type
Traditional
Product code
MND
Device class
2
Regulation number
876.4400
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Melville, NY, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Olympus America

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
AUTOBAND LIGATOR (K132535)Endochoice, Inc.2013-08-23
MODIFICATION TO AUTO-BAND LIGATOR (K083556)Scandimed International2009-02-19
AUTO-BAND LIGATOR (K081142)Scandimed International2008-05-16
INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 (K051950)Ethicon Endo-Surgery, Inc.2005-10-07
AUTO-BAND LIGATOR (K031236)Scandimed. A.S.2003-11-14
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U (K033245)C.R. Bard, Inc.2003-11-06
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U (K022434)C.R. Bard, Inc.2002-08-05
OLYMPUS ENDOSCOPIC LIGATION DEVICE (K001744)Olympus America, Inc.2001-02-27
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 (K990864)Boston Scientific Corp1999-06-11
OLYMPUS HX-20 SERIES LIGATING DEVICE (K984255)Olympus Corp of America1999-01-12
HX-20/21-1 ENDOSCOPIC LIGATOR (K964661)Olympus America, Inc.1997-10-30
BARD RAPIDFIRE MULTIPLE BAND LIGATOR (K971137)C.R. Bard, Inc.1997-10-16

Recalls involving this device

RecordFirmDate
Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 sc recall (Z-1418-2023)Olympus Corporation of the Americas2023-04-20