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UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) (K254252): 510(k) cleared for Karl Storz SE & CO. KG vs KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG: FDAPulse comparison

UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) (K254252): 510(k) cleared for Karl Storz SE & CO. KG's review days of 270 is 1.0x KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG's 267 (94th percentile). UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) (K254252): 510(k) cleared for Karl Storz SE & CO. KG is dated 2026-09-25; KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG 2026-09-24.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

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How does UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) (K254252): 510(k) cleared for Karl Storz SE & CO. KG compare to KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG?

FieldUNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) (K254252): 510(k) cleared for Karl Storz SE & CO. KGKARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG
Record510(k) clearance510(k) clearance
510(k) numberK254252K254303
DeviceUNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)KARL STORZ SUPRALOOP
ApplicantKarl Storz SE & CO. KGKarl Storz SE & CO. KG
Specialty / panelObstetrics/GynecologyObstetrics/Gynecology
Product codeHIHKNF
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2025-12-292025-12-31
Decision date2026-09-252026-09-24
Review time (days)270267
Third-party reviewNoNo
Applicant locationTuttlingen, DETuttlingen, DE, US
amount percentile94th88th
Predicate Speed & CAPA Advisory Opportunity Score61/10061/100
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Official records: UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) (K254252): 510(k) cleared for Karl Storz SE & CO. KG · KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG

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