Atlas FDA

AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS

FDA 510(k) clearance K121426 · decided 2012-07-10

Clearance details

K-number
K121426
Device name
AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS
Applicant
Synergetics, Inc.
Decision
Substantially Equivalent
Date received
2012-05-14
Decision date
2012-07-10
Days to decision
57 days
Clearance type
Traditional
Product code
GEI
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
O' Fallon, MO, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number recall (Z-0239-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number recall (Z-0240-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number recall (Z-0241-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number recall (Z-0242-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number recall (Z-0243-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number recall (Z-0244-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number recall (Z-0245-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number recall (Z-0246-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number recall (Z-0247-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number recall (Z-0248-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number recall (Z-0249-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number recall (Z-0250-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number recall (Z-0251-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 678 recall (Z-0252-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 678 recall (Z-0253-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 678 recall (Z-0254-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 678 recall (Z-0255-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 678 recall (Z-0256-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 678 recall (Z-0257-2024)Stryker Corporation2023-11-07