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

Morgan Hill, CA, US

SHEATHING TECHNOLOGIES, INC. appears in FDA device records in Morgan Hill, CA. FDA records list 7 510(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
7
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 7 510(k) clearances for Sheathing Technologies Inc between 1999 and 2016. The busiest year on record is 1999, with 1. The most recent is 2016, with 1.

Clearances by year, as a table
510(k) clearance decisions for Sheathing Technologies Inc, by decision year
YearClearances
19991
20051
20091
20101
20121
20131
20161
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K153212Sheathes Ultrasound Probe CoversITXSubstantially Equivalent
K130041SHEATHES STERILE ULTRASOUND GELMUISubstantially Equivalent
K112827SHEATHES ULTRASOND GELMUISubstantially Equivalent
K100966COLONOSCOPE/SIGMOIDOSCOPE SHEATHESFDFSubstantially Equivalent
K091828SHEATHESISO ULTRASOUND TRANSDUCER COVERITXSubstantially Equivalent
K043425SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)ITXSubstantially Equivalent
K990175SHEATHES (NON-LATEX), STERILEITXSubstantially Equivalent

Registered establishments

FDA registered establishments for Sheathing Technologies Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
29507761000135740SHEATHING TECHNOLOGIES, INC.675 JARVIS DR., MORGAN HILL, CA 95037 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-1006-2026Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.Class IIOpen, Classified

Verification record

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