MAUDE MDR 9733378

Manufacturer Contact#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	MCRYL VIO 36IN 2-0 S/A FS-1	SUTURE, ABSORBABLE, SYNTHETIC	ETHICON INC.	GAN	Y943G	Y943G	MHZ100				Y	R

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2020-02-20	0

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
10705031463998	MONOCRYL	ETHICON, LLC	GAN	2023-08-28
10705031470354	MONOCRYL	ETHICON, LLC	GAN	2023-08-28
10705031470361	MONOCRYL	ETHICON, LLC	GAN	2023-08-28
10705031470385	MONOCRYL	ETHICON, LLC	GAN	2023-08-28
10705031470392	MONOCRYL	ETHICON, LLC	GAN	2023-08-28
30705031470358	MONOCRYL	ETHICON, LLC	GAN	2023-08-28
30705031470396	MONOCRYL	ETHICON, LLC	GAN	2023-08-28
10705031059764	MONOCRYL	ETHICON, LLC	GAN	2023-05-17
10705031135017	MONOCRYL	ETHICON, LLC	GAN	2023-05-17
10705031135024	MONOCRYL	ETHICON, LLC	GAN	2023-05-17
10705031135031	MONOCRYL	ETHICON, LLC	GAN	2023-05-17
30705031059768	MONOCRYL	ETHICON, LLC	GAN	2023-05-17
30705031135028	MONOCRYL	ETHICON, LLC	GAN	2023-05-17
30705031135035	MONOCRYL	ETHICON, LLC	GAN	2023-05-17
07757093001539	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001553	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001560	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001621	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001638	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001652	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001683	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001829	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001898	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001959	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001973	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001997	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093002017	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093002093	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093002123	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093218449	SUTUMED	Unilene S.A.C.	GAN	2023-01-09

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K003015	GAN	SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD	Surgical Specialties Corp	2000-12-15
510(k)	K964072	GAN	MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED	ETHICON, Inc.	1996-12-18
510(k)	K960653	GAN	MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)	ETHICON, Inc.	1996-03-28
510(k)	K951231	GAN	ORTHOPEDIC PACKS	Sterile Concepts, Inc.	1995-12-01
510(k)	K920978	GAN	ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED	ETHICON, Inc.	1994-02-15
PMA	N17472S043	GAN	VICRYL (POLYGLACTIN 910) SUTURE	ETHICON, Inc.	1987-10-05
PMA	N17472S042	GAN	VICRYL (POLYGLACTIN 910) SUTURE	ETHICON, Inc.	1987-08-28
PMA	N17482S035	GAN	VICRYL MESH	ETHICON, Inc.	1987-06-18
PMA	N17472S041	GAN	VICRYL (POLYGLACTIN 910) SUTURE	ETHICON, Inc.	1987-06-18
PMA	N17482S034	GAN	VICRYL MESH	ETHICON, Inc.	1986-12-03