Home / 510(k) Clearances / K961460

510(k) K961460

LWEET CONE BIOPSY INSTRUMENT by Apple Medical Corp. — Product Code HGI

K961460 is an FDA 510(k) premarket notification submitted by Apple Medical Corp. for the device "LWEET CONE BIOPSY INSTRUMENT". The FDA issued a decision of Substantially Equivalent on November 19, 1996. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120. Apple Medical Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1996
Date Received
April 16, 1996
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 Apple Medical Corp.

  • K061651 — FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 (October 20, 2006)
  • K050256 — APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR (April 26, 2005)
  • K041131 — APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR (May 13, 2004)
  • K014005 — APPLE MEDICAL MOBIUS ELASTIC RETRACTOR (February 15, 2002)
  • K000026 — APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER (March 31, 2000)
  • K970788 — PNEUMO-MATIC INSUFFLATION NEEDLE (March 27, 1997)
  • K952841 — THE ASSISTANT (August 18, 1995)
  • K941506 — URETERAL ILLUMINATOR (October 5, 1994)

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)
  • K003608 — SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY (February 20, 2001)
  • K002042 — TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 (February 1, 2001)
  • K993527 — LOOP ELECTRODE, BALL ELECTRODE (July 6, 2000)

FDA data resources