510(k) K990687

HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS by Olympus Optical, Co. — Product Code PKL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 26, 1999
Date Received: March 1, 1999
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Hemostatic Metal Clip For The Gi Tract
Device Class: Class II
Regulation Number: 876.4400
Review Panel: GU
Submission Type

Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.

Other clearances by Olympus Optical, Co.

K032066 — SONOSURG SYSTEM (October 3, 2003)
K030194 — XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT (March 24, 2003)
K021962 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (February 12, 2003)
K023984 — MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SE (January 31, 2003)
K023272 — DISPOSABLE ASPIRATION NEEDLE NA-200H (December 23, 2002)
K023767 — UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES (November 29, 2002)
K012074 — XBO1-824-18/19/20 BIOPSY FORCEPS (September 25, 2001)
K012073 — OLYMPUS SPRAY CATHETER PW-6C-1 (August 10, 2001)
K011869 — XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT (July 25, 2001)
K011149 — DISPOSABLE BENDING CANNULA PR-233Q (May 15, 2001)

Other clearances for product code PKL

K253734 — Taurus Clip (March 12, 2026)
K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n) (December 18, 2025)
K252271 — Hemoclip (November 12, 2025)
K250229 — Dual Action Tissue Closure Device (September 8, 2025)
K250842 — PADLOCK CLIP EFTR Kit (00713229) (April 18, 2025)
K250066 — Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M0052 (February 6, 2025)
K241005 — Haemostasis Clips (January 2, 2025)
K240274 — PADLOCK CLIP EFTR Kit (00713229) (September 17, 2024)
K241858 — BARS Set (100.60) (August 26, 2024)
K234124 — Single Use Hemoclips (July 12, 2024)