Smith & Nephew Endoscopy, Inc.

Andover, MA, US

Smith & Nephew Endoscopy, Inc. appears in FDA device records in Andover, MA. FDA records list 18 510(k) clearances between 1996-07-16 and 2011-02-03, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 18
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 18 510(k) clearances for Smith & Nephew Endoscopy, Inc. between 1996 and 2011. The busiest year on record is 1997, with 5. The most recent is 2011, with 1.

Clearances by year, as a table

510(k) clearance decisions for Smith & Nephew Endoscopy, Inc., by decision year
Year	Clearances
1996	4
1997	5
1999	1
2000	1
2005	1
2008	1
2009	3
2010	1
2011	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K103309	OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS	MAI	Substantially Equivalent	2011-02-03
K102660	BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS	MBI	Substantially Equivalent	2010-12-13
K093428	SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR	MBI	Substantially Equivalent	2009-12-17
K083635	SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW	MBI	Substantially Equivalent	2009-01-30
K083226	SMITH & NEPHEW PEEK INTERFERENCE SCREW	MBI	Substantially Equivalent	2009-01-30
K082095	ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE	HTN	Substantially Equivalent	2008-10-21
K050580	SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS	HRX	Substantially Equivalent	2005-04-20
K992396	BIORCI SCREW	HWC	Substantially Equivalent	2000-01-12
K991500	SMITH & NEPHEW SUTURE LOK	OCW	Substantially Equivalent	1999-07-14
K972599	ACUFEX SCREW CANNULA	HWC	Substantially Equivalent	1997-09-19
K971939	SMITH & NEPHEW SUTURE COLLET	OCW	Substantially Equivalent	1997-08-06
K970949	SMITH & NEPHEW MIS INSTRUMENTS	GCJ	Substantially Equivalent	1997-04-23
K970416	ACUFEX DOUBLE ARMED SUTURE NEEDLE	GAT	Substantially Equivalent	1997-04-21
K964935	SUTURE LOCK	KGS	Substantially Equivalent	1997-02-25
K964215	ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM	HRX	Substantially Equivalent	1996-12-20
K963901	ELECTROSURGICAL PROBE	GEI	Substantially Equivalent	1996-11-04
K962789	SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM	GEY	Substantially Equivalent	1996-08-14
K961649	ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER	HWC	Substantially Equivalent for Some Indications	1996-07-16

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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What MDM checks, and what it does not

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain