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510(k) K884347

MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN by Advanced Surgical Products, Inc. — Product Code GXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1988
Date Received
October 14, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Radiofrequency Lesion
Device Class
Class II
Regulation Number
882.4725
Review Panel
NE
Submission Type

Other clearances by Advanced Surgical Products, Inc.

  • K030926 — FAST THROW STAINLESS STEEL SURGICAL SUTURE (July 21, 2003)
  • K895800 — ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR (January 22, 1990)
  • K896754 — I/A HANDPIECE (January 11, 1990)
  • K896305 — MULTI-USE I/A HANDPIECE (December 18, 1989)
  • K884557 — ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE (May 12, 1989)
  • K884556 — DREYER CURVED ENDOILLUMINATOR (February 28, 1989)
  • K890398 — RYAN-STYLE DIRECTED INFUSION MANIPULATOR (February 17, 1989)
  • K883857 — FIBEROPTIC WIRE PICK LIGHTPIPE (September 29, 1988)
  • K883858 — FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE (September 29, 1988)
  • K883856 — FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE (September 29, 1988)

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  • K241367 — RF Cannula (January 23, 2025)
  • K222281 — Intracept Intraosseous Nerve Ablation System (October 26, 2022)
  • K213836 — Intracept Intraosseous Nerve Ablation System (March 11, 2022)
  • K203066 — COOLIEF Cooled Radiofrequency Kit Advanced (December 22, 2020)
  • K190259 — Vesta RF Cannula (February 7, 2020)
  • K191293 — LCCS VC-S RF Cannula (January 24, 2020)