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510(k) K860593

ET/RT PAPILLOTOME by Hobbs Medical, Inc. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1986
Date Received
February 19, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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  • K030765 — HOBBS MISTIFIER SPRAY CATHETER (June 9, 2003)
  • K933354 — HOBBS MEDICAL CLEANING BRUSH (October 28, 1993)
  • K922396 — FUJINON FORCEPS -- MODIFICATION (December 10, 1992)
  • K921026 — PRESSURE GAUGE (April 24, 1992)
  • K914358 — ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP (November 19, 1991)
  • K893729 — HOBBS MEDICAL MICROBIOLOGY BRUSH (August 28, 1989)
  • K872509 — LINDEN STONE EXTRACTION BALLOON (September 22, 1987)

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  • K241855 — SB Knife Jr2 (MD-47702 and MD-47702L) (March 26, 2025)
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