510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Surgical Dynamics Ltd

Consett Durham, GB

SURGICAL DYNAMICS LTD appears in FDA device records in Consett Durham, GB. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
12
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 12 510(k) clearances for Surgical Dynamics Ltd between 1989 and 1996. The busiest year on record is 1995, with 3. The most recent is 1996, with 1.

Clearances by year, as a table
510(k) clearance decisions for Surgical Dynamics Ltd, by decision year
YearClearances
19892
19901
19912
19932
19941
19953
19961
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K960046SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPEHRXSubstantially Equivalent
K942987NUCLEOTOME L KITGETSubstantially Equivalent
K954193SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SETHRXSubstantially Equivalent
K950495SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000BTASubstantially Equivalent
K931109NUCLEOTOME E KITHRXSubstantially Equivalent for Some Indications
K921950SURGICAL DYNAMICS DISCOGRAPHY SYSTEMFMIUnknown
K923525NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBARHRXSubstantially Equivalent
K914282NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTERHRXSubstantially Equivalent
K913145NUCLEOTOME TISSUE ASPIRATOR/CUTTERHRXSubstantially Equivalent
K902778SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTERHRXSubstantially Equivalent
K894336SURGICAL DYNAMICS DISCOGRAPHY SYSTEMUnknown
K885066HEMATOME SYSTEMGETSubstantially Equivalent

Registered establishments

FDA registered establishments for Surgical Dynamics Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30141109843014110984SURGICAL DYNAMICS LTDUnit 35A Werdohl Way, Consett Durham DH8 6SZ GB2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

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

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain