TLS BULB DRAINAGE SYSTEM— 510(k) K833586

Name: FDA 510(k) clearance K833586
Creator: U.S. Food and Drug Administration
Published: 1984-01-30

Substantially Equivalent

Porex Medical

FDA 510(k) clearance K833586 for TLS BULB DRAINAGE SYSTEM, Substantially Equivalent on 1984-01-30. Applicant: Porex Medical. Device class: 1.

Clearance details

Applicant: Porex Medical
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
Advisory panel: General, Plastic Surgery
Date received: 1983-10-12
Decision date: 1984-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GCY

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K972703 — REDYROB-CLOSED WOUND DRAINAGE SYSTEM1997-10-01
K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICE1997-06-03
K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-5001996-12-12
K960099 — PENROSE DRAIN MODELS 6001 - 60071996-03-11
K950754 — MACRO SUCTION TUBE MODEL NO 100611995-04-25

More clearances from Porex Medical

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K872791 — POREX NERVE LOCATOR1987-10-20
K873044 — POREX OTOLOGY INSTRUMENTS1987-09-04
K872947 — POREX QUALITY PLASTIC SURGERY INSTRUMENTS1987-08-21
K863943 — POREX(TM) EYE SPHERE IMPLANT1987-02-27
K863946 — POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT1987-02-27

Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K833586

K-number listed on FDA's recall record

Z-1149-2017 — QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage SystemClass II·Terminated·Stryker Leibinger GmbH & Co. KG·20170103
Z-1150-2017 — 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor ImplantsClass II·Terminated·Stryker Leibinger GmbH & Co. KG·20170103

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K833586.

Data sourced from openFDA. This site is unofficial and independent of the FDA.