CUSTOMED CYSTO PACK I— 510(k) K902274
UnknownCustomed, Inc.
FDA 510(k) clearance K902274 for CUSTOMED CYSTO PACK I, Unknown on 1990-09-20. Applicant: Customed, Inc.. Device class: 2.
Clearance details
- Applicant
- Customed, Inc.
- Product code
- Code FAJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Puerto Rico, US
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- K253905 — PrimeSight UltraView System
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More clearances from Customed, Inc.
view all- K974647 — FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
- K971920 — GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
- K964011 — SUCTION CATHETER TRAY PRODUCT NO. 900277
- K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
- K962596 — CUSTOMED BLOOD EXTRACTION KIT
Adverse events under product code FAJ
product code FAJ- Injury
- 533
- Malfunction
- 6,705
- Total
- 7,238
Source: openFDA MAUDE database, through . 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 K902274
K-number listed on FDA's recall record- Z-1407-2016 — Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-1463-2016 — Catalog Number: 9002899 CYSTO TUR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-2558-2015 — CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
- Z-2660-2015 — CYSTO TUR PACK BASIC 8/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
- Z-2678-2015 — CYSTO TUR PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K902274.
Data sourced from openFDA. This site is unofficial and independent of the FDA.