Product code GDY— General, Plastic Surgery
ULTRACELL ORTHOPEDIC SPONGES
- Classification name
- Gauze/Sponge, Internal, X-Ray Detectable
- Device class
- Class 1
- Regulation
- 21 CFR 878.4450
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 111
- First cleared
- Most recent
Market context for product code GDY
FDA has cleared devices under product code GDY between 1977 and 1997, filed by 61 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
Top applicants under product code GDY
Adverse events under product code GDY
product code GDY- Malfunction
- 764
- Total
- 764
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 →
Recent clearances under product code GDY
1–100 of 111- K972634 — ULTRACELL SUCTION SPONGE
- K960236 — CPR LAP SPONGES
- K955599 — STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
- K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE
- K953830 — KENSORB
- K953057 — CYLINDRICAL SPONGE
- K953058 — ROUND STICK SPONGES, FLAT STICK SPONGES
- K953059 — KITTNER DISSECTOR
- K953060 — ROSEBUD DISSECTOR
- K953062 — CHERRY DISSECTOR
- K953087 — CHERRY PIT DISSECTOR
- K953088 — TRIANGULAR SPONGES
- K951911 — GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)
- K950370 — ULTRACELL ORTHOPEDIC SPONGES
- K950372 — ULTRACELL ORTHOPEDIC SPONGES
- K950373 — ULTRACELL ORTHOPEDIC SPONGES
- K950659 — ULTRACELL RETRACTOR COVERS
- K945333 — KITTNER DISSECTOR
- K945335 — CHERRY DISSECTOR
- K945553 — ROUND STICK SPONGES, FLAT STICK SPONGES
- K945606 — TRIANGULAR SPONGES
- K945866 — CYLINDRICAL SPONGE
- K944879 — GAUZE SPONGES
- K940764 — OREX
- K940766 — OREX (18X18 X-RAY DETECTABLE)
- K940767 — OREX (12X12 X-RAY DETECTABLE)
- K945332 — ROSEBUD DISSECTOR
- K945334 — CHERRY PIT DISSECTOR
- K945336 — PEANUT DISSECTOR
- K940436 — SPONGE, LAPAROTOMY, VARIOUS SIZE
- K942366 — LORREX GAUZE SPONGES, X-RAY DETECTABLE
- K941344 — LAP SPONGE PRODUCT LINE
- K941522 — STERILE X-RAY DETECTABLE GAUZE SPONGES
- K940756 — ISOLYSER (X-RAY DETECTABLE)
- K940757 — ISOLYSER (4X18) X-RAY DETECTABLE
- K940762 — ISOLYSER (18X18 X-RAY DETECTABLE)
- K940763 — ISOLYSER (8X4 12 PLY X-RAY DETECTABLE)
- K941217 — DUPAQUE SPONGE
- K934971 — STERILE LAPAROTOMY SPONGES
- K935883 — NEUROLOGICAL SPONGES
- K935993 — SURGICAL SPONGE X-RAY DETECTABLE
- K935881 — SPECIALTY SPONGES
- K935882 — TONSIL SPONGES
- K935910 — X-RAY PACKING SPONGE
- K932846 — TENCEL X-RAY DETECTABLE SPONGES/LAP PADS
- K922054 — STERILE GAUZE SPONGES X-RAY DETECTABLE
- K913303 — LAP SPONGES, MODIFIED
- K920355 — SPECIALTY SPONGES
- K920356 — SURGICAL SPONGES
- K913302 — DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED
- K914082 — SUAN FLAT DISSECTOR SPONGES
- K913794 — SIMPEX INC. SURGICAL DRESSING
- K914083 — ICAN K DISSECTOR SPONGES
- K905135 — LAPAROTOMY SPONGES
- K903358 — ADVANCE LAPAROTOMY SPONGE, LAP SPONGE
- K895372 — X-RAY DETECTABLE GAUZE SPONGE
- K894984 — MASCOT LAB SPONGE
- K884790 — QUALTEX NEUROLOK SURGICAL SPONGE
- K882707 — GAUZE PACKING, X-RAY DETECTABLE
- K882708 — GAUZE SPONGE, X-RAY DETECTABLE
- K882709 — TONSIL SPONGE, X-RAY DETECTABLE, W/STRING
- K873391 — MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8
- K872807 — NON-WOVEN TRACHEOTOMY SPONGE
- K872809 — GAUZE CHERRY SPONGE
- K864529 — LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36
- K863089 — DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000
- K854714 — X-RAY DETECTABLE COTTON BALLS
- K853742 — GAUZE SPONGE
- K842572 — GAUZE & LAB SPONGES STERILE & NON
- K840541 — NEURO SPONGE
- K833626 — FLORET FOAM PREP SPONGE
- K831914 — STRUNG NEURO SPONGE PATTIES-X-RAY-
- K831913 — COLOR-EZE PRE-WASHED LAP SPONGES
- K832172 — GAUZE SPONGE X-RAY DETECTABLE-
- K830260 — FLORET VAGINAL PACKING/TAMPONS
- K830511 — ZANLEX, ZAN-TEX & ZANDEX
- K830201 — POLYESTER X-RAY DETECTABLE STRUNG-SPONGE
- K830202 — COTTON BALLS, X-RAY OPAQUED STRUNG & NON
- K823671 — NO-GAUZE LAPAROTOMY SPONGE
- K822623 — LAPAROTOMY SPONGE
- K813286 — PRE-PACK TENS
- K813595 — PARKE-DAVIS AEGIS ABOSRBENT SPONGES
- K812390 — NEUROSPONGE PADDIE
- K812391 — NEUROSPONGES
- K812017 — X-RAY DETECTABLE BAND
- K812018 — X-RAY DETECTABLE THREAD
- K812831 — SURGICAL DRESSINGS
- K812707 — STERILE DISSECTOR SPONGES-X-RAY DETECT
- K812710 — STERILE LAPAROTOMY SPONGES-X-RAY DETECT
- K812651 — X-RAY DETECTABLE LAP SPONGES
- K812554 — TOMAC STERILE DISP. LAP SPONGE
- K811632 — UNSTERILIZED LAPAROTOMY SPONGES (CHINA)
- K811769 — LAPAROTOMY PADS
- K810184 — LAPAROTOMY SPONGE
- K803188 — GAUZE SPONGES
- K802982 — GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG.
- K802798 — OPRATEX ABDOMINAL PAD
- K802060 — STERILE TONSIL SPONGES
- K801768 — CONTAIN X-RAY DETECTABLE LAP SPONGE
- K800281 — MEDSPEC PACKING GAUZE
Data sourced from openFDA. This site is unofficial and independent of the FDA.