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510(k) K990687

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

K990687 is an FDA 510(k) premarket notification submitted by Olympus Optical, Co. for the device "HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS". The FDA issued a decision of Substantially Equivalent on March 26, 1999. The device falls under product code PKL (Hemostatic Metal Clip For The Gi Tract), a Class II device regulated under 21 CFR 876.4400. Olympus Optical, Co. has at least 10 other 510(k) clearances on record.

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)
  • K011151 — EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z (May 15, 2001)

Other clearances for product code PKL

  • K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX (May 21, 2026)
  • K252270 — Hemoclip (April 8, 2026)
  • 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)

FDA data resources