Medical Device Manufacturer · US , Bolton , MA

Apple Medical Corp.

9 submissions · 9 cleared · Since 1994
9
Total
9
Cleared
0
Denied

Apple Medical Corp. — FDA 510(k) Submissions

Apple Medical Corp. has submitted 9 FDA 510(k) premarket notifications since 1994, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrocautery, Gynecologic (and Accessories), Laparoscope, General & Plastic Surgery, Retractor, Light, Catheter, Fiberoptic, Glass, Ureteral, Clamp, Penile . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
K061651 · HGI Electrocautery,... · Obstetrics & Gynecology
Oct 2006 129d
APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
K050256 · GAD Retractor · General & Plastic Surgery
Apr 2005 82d
APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR
K041131 · GCJ Laparoscope, General &... · General & Plastic Surgery
May 2004 13d
APPLE MEDICAL MOBIUS ELASTIC RETRACTOR
K014005 · GCJ Laparoscope, General &... · General & Plastic Surgery
Feb 2002 72d
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
K000026 · HHK Curette, Suction,... · Obstetrics & Gynecology
Mar 2000 86d
PNEUMO-MATIC INSUFFLATION NEEDLE
K970788 · FHO Pneumoperitoneum Needle · Gastroenterology & Urology
Mar 1997 23d
LWEET CONE BIOPSY INSTRUMENT
K961460 · HGI Electrocautery,... · Obstetrics & Gynecology
Nov 1996 217d
THE ASSISTANT
K952841 · FHA Clamp, Penile · Gastroenterology & Urology
Aug 1995 58d
URETERAL ILLUMINATOR
K941506 · FCS Light, Catheter,... · Gastroenterology & Urology
Oct 1994 190d
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