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

Lorton, VA, US

SURGICAL DESIGN, INC. appears in FDA device records in Lorton, VA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
4
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 4 510(k) clearances for Surgical Design Inc between 1994 and 2005. The busiest year on record is 1994, with 1. The most recent is 2005, with 1.

Clearances by year, as a table
510(k) clearance decisions for Surgical Design Inc, by decision year
YearClearances
19941
19961
19991
20051
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K043533SURGICAL DESIGN CIRCUMCISION CLAMPHFXSubstantially Equivalent
K991852OCUSYSTEM ART ADVANTAGE, MODEL 995HQCSubstantially Equivalent
K961243OCUSYSTEM ART ADVANTAGEHQCSubstantially Equivalent
K934817SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESSFNMSubstantially Equivalent

Registered establishments

FDA registered establishments for Surgical Design Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
11252363001236105SURGICAL DESIGN, INC.7351-D LOCKPORT PL., LORTON, VA 22079 US2026

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2153-2011Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.Medical device used in surgical procedure is defective and may break during use.Terminated

Verification record

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