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

Tuebingen Baden-Wurttemberg, DE

OVESCO ENDOSCOPY AG appears in FDA device records in Tuebingen Baden-Wurttemberg, DE. FDA records list 14 510(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
14
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 14 510(k) clearances for Ovesco Endoscopy AG between 2010 and 2025. The busiest year on record is 2014, with 2. The most recent is 2025, with 2.

Clearances by year, as a table
510(k) clearance decisions for Ovesco Endoscopy AG, by decision year
YearClearances
20101
20142
20152
20161
20172
20191
20201
20221
20241
20252
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)PKLSubstantially Equivalent
K242586ArgoCap (200.52)OCXSubstantially Equivalent
K241858BARS Set (100.60)PKLSubstantially Equivalent
K221385LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)PLLSubstantially Equivalent
K200684gastroduodenal FTRD SetPKLSubstantially Equivalent
K183309stentfix OTSC System SetPKLSubstantially Equivalent
DEN160014remOVE SystemQAGUnknown
K170867FTRD System SetPKLSubstantially Equivalent
K153550FTRD System SetPKLSubstantially Equivalent
K150067OTSC ProctologyPKLSubstantially Equivalent
K141790AQANIFEGEISubstantially Equivalent
K141794ENDO-MARYLAND DISSECTORKGESubstantially Equivalent
K140923TRACTION POLYPECTOMY SNAREFDISubstantially Equivalent
K101428OTSC (OVER-THE SCOPE-CLIP) SYSTEM SETPKLSubstantially Equivalent

Registered establishments

FDA registered establishments for Ovesco Endoscopy AG, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30066966073006696607OVESCO ENDOSCOPY AGFriedrich-Miescher-Strasse 9, Tuebingen Baden-Wurttemberg 72076 DE2026and 6 more, listed in full below

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

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