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Sponge, Ophthalmic

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
886.4790
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.4790 Ophthalmic sponge

§ 886.4790 Ophthalmic sponge.

(a) Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]

Sponge, Ophthalmic

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
886.4790
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.4790 Ophthalmic sponge

§ 886.4790 Ophthalmic sponge.

(a) Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]