Reprocessed Endoscopic Trocars and Sleeves— 510(k) K201511
Substantially EquivalentStryker Sustainability Solutions
FDA 510(k) clearance K201511 for Reprocessed Endoscopic Trocars and Sleeves, Substantially Equivalent on 2020-07-31. Applicant: Stryker Sustainability Solutions. Device class: 2.
Clearance details
- Applicant
- Stryker Sustainability Solutions
- Product code
- Product code NLM
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tempe, AZ, US
Recent devices under product code NLM
view all- K182828 — Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
- K172097 — Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves
- K172093 — Reprocessed Covidien Trocar
- K160740 — Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
- K153258 — Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
More clearances from Stryker Sustainability Solutions
view all- K260636 — Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
- K250898 — Reprocessed HARMONIC 700 Shears (3 models)
- K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000) +3 more
- K241606 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120) +1 more
- K233471 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120) +1 more
Recalls naming K201511
K-number listed on FDA's recall record- Z-3183-2026 — REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
- Z-3187-2026 — REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
- Z-3186-2026 — REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM
- Z-3185-2026 — REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
- Z-3184-2026 — REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM
- Z-3182-2026 — REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201511.
Data sourced from openFDA. This site is unofficial and independent of the FDA.