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510(k) K003608

SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY by Aesculap, Inc. — Product Code HGI

K003608 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY". The FDA issued a decision of Substantially Equivalent on February 20, 2001. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120. Aesculap, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2001
Date Received
November 22, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocautery, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.4120
Review Panel
OB
Submission Type

Other clearances by Aesculap, Inc.

  • K242762 — Aesculap Aicon® Series Container System (May 13, 2025)
  • K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (December 16, 2024)
  • K223596 — SQ.line KERRISON (June 29, 2023)
  • K214041 — Aesculap AICON Container (December 30, 2022)
  • K211572 — Aesculap Slim Clip Applier (December 13, 2021)
  • K203739 — ELAN 4 Electro Motor System (August 24, 2021)
  • K202391 — DIR 800 (January 21, 2021)
  • K203461 — Aesculap Caiman 12 Seal and Cut Technology System (December 18, 2020)
  • K202938 — Aesculap Caiman 5 Seal and Cut Technology System (October 30, 2020)
  • K202124 — Aesculap PAS-Port Proximal Anastomosis System (September 2, 2020)

Other clearances for product code HGI

  • K202915 — IRIS Thermocoagulator and Digital Colposcope (April 23, 2021)
  • K152843 — Liger Medical HTU-110 (June 24, 2016)
  • K130606 — FMWAND FERROMAGNETIC SURGICAL SYSTEM (January 3, 2014)
  • K121881 — DOMAIN SURGICAL SYSTEM (October 18, 2012)
  • K070877 — ENDOCERVICAL ELECTRODE # 2 (July 27, 2007)
  • K061651 — FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 (October 20, 2006)
  • K022593 — THOMAS MEDICAL ELECTRODES (November 1, 2002)
  • K002042 — TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 (February 1, 2001)
  • K993527 — LOOP ELECTRODE, BALL ELECTRODE (July 6, 2000)
  • K993777 — DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES (May 25, 2000)

FDA data resources