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Company · US

Apple Medical Corp.

FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2006. Name variants (Inc, Corp, punctuation) are merged.

9510(k) clearances (0 in 12 months)

8recalls (0 in 12 months)

8recalls that name a 510(k)

Product codes

Code	Device	Records
HGI	Electrocautery, Gynecologic (And Accessories)	10
GCJ	Laparoscope, General & Plastic Surgery	2
FCS	Light, Catheter, Fiberoptic, Glass, Ureteral	1
FHA	Clamp, Penile	1
FHO	Pneumoperitoneum Needle	1
GAD	Retractor	1
HHK	Curette, Suction, Endometrial (And Accessories)	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Oct 20, 2006	K061651	FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 Apple Medical Corp.	HGI
Apr 26, 2005	K050256	APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR Apple Medical Corp.	GAD
May 13, 2004	K041131	APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR Apple Medical Corp.	GCJ
Feb 15, 2002	K014005	APPLE MEDICAL MOBIUS ELASTIC RETRACTOR Apple Medical Corp.	GCJ
Mar 31, 2000	K000026	APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER Apple Medical Corp.	HHK
Mar 27, 1997	K970788	PNEUMO-MATIC INSUFFLATION NEEDLE Apple Medical Corp.	FHO
Nov 19, 1996	K961460	LWEET CONE BIOPSY INSTRUMENT Apple Medical Corp.	HGI
Aug 18, 1995	K952841	THE ASSISTANT Apple Medical Corp.	FHA
Oct 5, 1994	K941506	URETERAL ILLUMINATOR Apple Medical Corp.	FCS

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Apr 6, 2006	Apple Medical Corporation Fischer Cone Biopsy Excisor Model: 900-158 Terminated	HGI	K961460
Apr 6, 2006	Apple Medical Corporation Fischer Cone Biopsy Excisor Model: 900-157 Terminated	HGI	K961460
Apr 6, 2006	Apple Medical Corporation Fischer Cone Biopsy Excisor - Dual Sets Model: 900-156 Terminated	HGI	K961460
Apr 6, 2006	Apple Medical Corporation Fischer Cone Biopsy Excisor - Lg - Shallow Model: 900-155 Terminated	HGI	K961460
Apr 6, 2006	Apple Medical Corporation Fischer Cone Biopsy Excisor - Medium - Ext Model: 900-154 Terminated	HGI	K961460
Apr 6, 2006	Apple Medical Corporation Fischer Cone Biopsy Excisor - Large Model: 900-152 Terminated	HGI	K961460
Apr 6, 2006	Apple Medical Corporation Fischer Cone Biopsy Excisor - Medium Model: 900-151 Terminated	HGI	K961460
Apr 6, 2006	Apple Medical Corporation Fischer Cone Biopsy Excisor - Small Model: 900-150 Terminated	HGI	K961460

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