Product code EXD— Gastroenterology, Urology

FDA has cleared 12 devices under product code EXD between 1977 and 2012, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20121 clearance
• 19921 clearance
• 19901 clearance
• 19871 clearance
• 19841 clearance
• 19831 clearance
• 19821 clearance
• 19811 clearance
• 19792 clearances
• 19772 clearances

• Vabar Corp.2 clearances
• Coloplast A/S2 clearances
• Sherwood Medical Industries1 clearance
• Qualitone1 clearance
• Palex Intl. SA1 clearance
• I.B. Bloxom C/O Hogan & Hartson1 clearance
• Howmedica Corp.1 clearance
• E. R. Squibb & Sons, Inc.1 clearance
• Cook Urological, Inc.1 clearance
• Convatec, A Division of E.R. Squibb & Sons1 clearance

• K121833 — OSTOMY IRRIGATION SETColoplast A/S·2012-07-16
• K914692 — URINARY DIVERSION EVACUATING CATHETERCook Urological, Inc.·1992-07-02
• K904586 — PALEX IRRIGATION SETPalex Intl. SA·1990-12-28
• K871791 — BLOXOM IRRIGATORI.B. Bloxom C/O Hogan & Hartson·1987-05-20
• K840268 — IRRIGATION SYSTEMColoplast A/S·1984-04-05
• K832299 — VISI-FLOW IRRIGATORConvatec, A Division of E.R. Squibb & Sons·1983-08-26
• K823274 — UNI-TIP COLOSTOMY IRRIGATION CONEHowmedica Corp.·1982-12-07
• K811160 — SUR-FIT IRRIGATION SLEEVEE. R. Squibb & Sons, Inc.·1981-06-02
• K790749 — COLOSTOMY ENEMA DEVICEVabar Corp.·1979-05-16
• K790750 — COLOSTOMY DEVICE W/ PRESSURE LIDVabar Corp.·1979-05-14
• K760810 — TUBE, GASTRO-ENTEROSTOMYSherwood Medical Industries·1977-02-28
• K770251 — SUPER X ADJUSTRETTEQualitone·1977-02-28